Trial Outcomes & Findings for Telemedicine in High-Risk Cardiovascular Patients Post-ACS (NCT NCT05015634)
NCT ID: NCT05015634
Last Updated: 2026-03-17
Results Overview
At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
337 participants
Primary outcome timeframe
6 months
Results posted on
2026-03-17
Participant Flow
Participant milestones
| Measure |
Active Arm
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
168
|
|
Overall Study
COMPLETED
|
169
|
168
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All randomized participants with available age data were included in this analysis. This measure reflects the age of participants included in the baseline analysis population.
Baseline characteristics by cohort
| Measure |
Active Arm
n=169 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=168 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years)
|
57.6 years
STANDARD_DEVIATION 8.7 • n=10 Participants • All randomized participants with available age data were included in this analysis. This measure reflects the age of participants included in the baseline analysis population.
|
58.6 years
STANDARD_DEVIATION 9.7 • n=50 Participants • All randomized participants with available age data were included in this analysis. This measure reflects the age of participants included in the baseline analysis population.
|
58.1 years
STANDARD_DEVIATION 9.2 • n=108 Participants • All randomized participants with available age data were included in this analysis. This measure reflects the age of participants included in the baseline analysis population.
|
|
Sex: Female, Male
Female
|
25 Participants
n=10 Participants
|
22 Participants
n=50 Participants
|
47 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=10 Participants
|
146 Participants
n=50 Participants
|
290 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=10 Participants
|
61 Participants
n=50 Participants
|
120 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=10 Participants
|
16 Participants
n=50 Participants
|
36 Participants
n=108 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=10 Participants
|
78 Participants
n=50 Participants
|
156 Participants
n=108 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=10 Participants
|
13 Participants
n=50 Participants
|
25 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Current or ex-smoker
|
100 Participants
n=10 Participants
|
96 Participants
n=50 Participants
|
196 Participants
n=108 Participants
|
|
Diabetes
|
46 Participants
n=10 Participants
|
49 Participants
n=50 Participants
|
95 Participants
n=108 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Time to readmission
At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.
Outcome measures
| Measure |
Active Arm
n=165 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=167 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Number of Participants With Hospital Readmission at 6 Months
|
13 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsAny emergency department visits not requiring admission or further intervention will be compared in both study groups at 6 months of follow up.
Outcome measures
| Measure |
Active Arm
n=163 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=167 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Emergency Department Visits at 6 Months
|
39 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: From discharge to 9 months follow-upPopulation: Total length of stay 0-9 months
Length of stay at 3, 6, and 9 months will be compared in both study groups.
Outcome measures
| Measure |
Active Arm
n=160 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=165 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Length of Stay
|
1.2 Days
Standard Deviation 5.6
|
1.8 Days
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All-cause Mortality at 6-month follow-up
At 6 months of follow up, compare all-cause mortality, morbidity
Outcome measures
| Measure |
Active Arm
n=163 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=167 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
All-cause Mortality
|
1.2 percentage of Events (95% CI)
Interval 0.3 to 4.9
|
1.2 percentage of Events (95% CI)
Interval 0.3 to 4.7
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Number of participants with major adverse cardiac events (MACE) at 9 months follow-up.
Number of participants with major adverse cardiac events (MACE) at 9 months follow-up.
Outcome measures
| Measure |
Active Arm
n=163 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=167 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE) at 9 Months
|
17 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Coronary angiography /angioplasty at 6 months
Compare Medical intervention for for acute coronary syndromes or heart failure, including coronary angiography/ angioplasty, injectable therapy or oxygen therapy for both study groups when readmission to hospital.
Outcome measures
| Measure |
Active Arm
n=160 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=165 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Medical Intervention
|
4 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: 3-month readmission data was not a pre-specified secondary outcome in the protocol; therefore, these data are not summarized in an outcome measure table.
The readmission rates for 9 months will be compared in both study groups.
Outcome measures
| Measure |
Active Arm
n=163 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=167 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
9 Months Readmission Rates
|
20 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Analysis includes only participants who completed the SF-36 and SAQ-7 questionnaires at 3-month follow-up time and had corresponding baseline data. The number of participants analyzed is therefore smaller than the number originally assigned to each arm in the Participant Flow, due to non-return of mailed questionnaires and missed follow-up assessments.
Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 3 months post-discharge, and follow-up scores were compared with baseline values.
Outcome measures
| Measure |
Active Arm
n=90 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=90 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Patient-Reported Quality of Life - 3 Months
SF-36 physical function
|
67.5 Units on a Scale
Standard Deviation 29.8
|
68.9 Units on a Scale
Standard Deviation 27.2
|
|
Patient-Reported Quality of Life - 3 Months
SF-36 role physical
|
57.5 Units on a Scale
Standard Deviation 44.9
|
52.5 Units on a Scale
Standard Deviation 44.2
|
|
Patient-Reported Quality of Life - 3 Months
SF-36 role emotional
|
63.7 Units on a Scale
Standard Deviation 44.3
|
60.0 Units on a Scale
Standard Deviation 43.9
|
|
Patient-Reported Quality of Life - 3 Months
SF-36 energy / vitality
|
53.9 Units on a Scale
Standard Deviation 20.0
|
51.2 Units on a Scale
Standard Deviation 20.5
|
|
Patient-Reported Quality of Life - 3 Months
SF-36 mental health
|
69.1 Units on a Scale
Standard Deviation 20.5
|
67.8 Units on a Scale
Standard Deviation 21.6
|
|
Patient-Reported Quality of Life - 3 Months
SF-36 social functioning
|
68.6 Units on a Scale
Standard Deviation 24.8
|
65.1 Units on a Scale
Standard Deviation 28.5
|
|
Patient-Reported Quality of Life - 3 Months
SF-36 pain
|
76.1 Units on a Scale
Standard Deviation 25.6
|
72.1 Units on a Scale
Standard Deviation 24.7
|
|
Patient-Reported Quality of Life - 3 Months
SF-36 general health
|
55.3 Units on a Scale
Standard Deviation 21.3
|
52.5 Units on a Scale
Standard Deviation 23.3
|
|
Patient-Reported Quality of Life - 3 Months
SAQ-7
|
70.8 Units on a Scale
Standard Deviation 21.9
|
70.4 Units on a Scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis includes only participants who completed the SF-36 and SAQ-7 questionnaires at the 6-month follow-up and had corresponding baseline data. The number of participants analyzed is therefore smaller than the number originally assigned to each arm in the Participant Flow, due to non-return of mailed questionnaires and missed follow-up assessments.
Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 6 months post-discharge, and follow-up scores were compared with baseline values.
Outcome measures
| Measure |
Active Arm
n=69 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=69 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Patient-Reported Quality of Life - 6 Months
SF-36 physical function
|
73.0 Units on a Scale
Standard Deviation 27.6
|
70.6 Units on a Scale
Standard Deviation 29.4
|
|
Patient-Reported Quality of Life - 6 Months
SF-36 role physical
|
65.9 Units on a Scale
Standard Deviation 42.2
|
63.0 Units on a Scale
Standard Deviation 44.5
|
|
Patient-Reported Quality of Life - 6 Months
SF-36 role emotional
|
70.0 Units on a Scale
Standard Deviation 43.2
|
71.0 Units on a Scale
Standard Deviation 43.1
|
|
Patient-Reported Quality of Life - 6 Months
SF-36 energy / vitality
|
56.0 Units on a Scale
Standard Deviation 20.8
|
52.3 Units on a Scale
Standard Deviation 20.9
|
|
Patient-Reported Quality of Life - 6 Months
SF-36 mental health
|
72.1 Units on a Scale
Standard Deviation 21.6
|
71.2 Units on a Scale
Standard Deviation 21.7
|
|
Patient-Reported Quality of Life - 6 Months
SF-36 social functioning
|
75.4 Units on a Scale
Standard Deviation 24.7
|
72.1 Units on a Scale
Standard Deviation 27.8
|
|
Patient-Reported Quality of Life - 6 Months
SF-36 pain
|
77.3 Units on a Scale
Standard Deviation 25.4
|
75.9 Units on a Scale
Standard Deviation 28.0
|
|
Patient-Reported Quality of Life - 6 Months
SF-36 general health
|
57.3 Units on a Scale
Standard Deviation 21.4
|
56.5 Units on a Scale
Standard Deviation 23.3
|
|
Patient-Reported Quality of Life - 6 Months
SAQ-7
|
74.7 Units on a Scale
Standard Deviation 20.6
|
72.9 Units on a Scale
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis includes only participants who completed the SF-36 and SAQ-7 questionnaires at the 9-month follow-up and had corresponding baseline data. The number of participants analyzed is therefore smaller than the number originally assigned to each arm in the Participant Flow, due to non-return of mailed questionnaires and missed follow-up assessments.
Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 9 months post-discharge, and follow-up scores were compared with baseline values.
Outcome measures
| Measure |
Active Arm
n=65 Participants
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=65 Participants
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Patient-Reported Quality of Life - 9 Months
SF-36 physical function
|
75.5 Units on a Scale
Standard Deviation 26.1
|
69.5 Units on a Scale
Standard Deviation 32.8
|
|
Patient-Reported Quality of Life - 9 Months
SF-36 role physical
|
71.2 Units on a Scale
Standard Deviation 39.8
|
59.2 Units on a Scale
Standard Deviation 45.4
|
|
Patient-Reported Quality of Life - 9 Months
SF-36 role emotional
|
79.0 Units on a Scale
Standard Deviation 38.9
|
66.2 Units on a Scale
Standard Deviation 43.9
|
|
Patient-Reported Quality of Life - 9 Months
SF-36 energy / vitality
|
56.3 Units on a Scale
Standard Deviation 17.2
|
53.3 Units on a Scale
Standard Deviation 25.7
|
|
Patient-Reported Quality of Life - 9 Months
SF-36 mental health
|
74.7 Units on a Scale
Standard Deviation 16.7
|
69.4 Units on a Scale
Standard Deviation 23.3
|
|
Patient-Reported Quality of Life - 9 Months
SF-36 social functioning
|
78.8 Units on a Scale
Standard Deviation 20.5
|
72.3 Units on a Scale
Standard Deviation 31.8
|
|
Patient-Reported Quality of Life - 9 Months
SF-36 pain
|
82.4 Units on a Scale
Standard Deviation 23.5
|
75.3 Units on a Scale
Standard Deviation 27.0
|
|
Patient-Reported Quality of Life - 9 Months
SF-36 general health
|
59.5 Units on a Scale
Standard Deviation 19.7
|
52.8 Units on a Scale
Standard Deviation 26.5
|
|
Patient-Reported Quality of Life - 9 Months
SAQ-7
|
77.0 Units on a Scale
Standard Deviation 18.4
|
72.4 Units on a Scale
Standard Deviation 20.3
|
Adverse Events
Active Arm
Serious events: 11 serious events
Other events: 0 other events
Deaths: 2 deaths
Control Arm
Serious events: 37 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Active Arm
n=163 participants at risk
Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.
Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
|
Control Arm
n=167 participants at risk
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
|
|---|---|---|
|
Vascular disorders
Stroke
|
1.8%
3/163 • Number of events 3 • Time to event 9-month follow-up
|
4.8%
8/167 • Number of events 8 • Time to event 9-month follow-up
|
|
Vascular disorders
Myocardial infarction
|
6.7%
11/163 • Number of events 11 • Time to event 9-month follow-up
|
22.2%
37/167 • Number of events 37 • Time to event 9-month follow-up
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place