Trial Outcomes & Findings for IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study) (NCT NCT01995552)
NCT ID: NCT01995552
Last Updated: 2019-08-20
Results Overview
Post MI mortality is higher in India than in the US and Western Europe. The hypothesis of the INSPIRE-ELR study was that occurrence of arrhythmias in the acute phase of MI will identify patients at highest risk and we evaluated the percentage clinical signification arrhythmias captured through the ELR post MI in acute phase
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
7 days post discharge
Results posted on
2019-08-20
Participant Flow
The study enrolled acute post MI patients with a reduced LVEF (≤35%) one day before or on the day of discharge from hospital after index MI. There is no control group in this study. The study was conducted in India and in multi specialty hospitals
The first patient was enrolled on April 29, 2014. Enrollment continued until the 250th patient was enrolled on January 31, 2016. out of 250, patients, there were 233 patients in the analysis cohort, with at least 72 hours of monitoring documented in the ELR device data or a clinically significant arrhythmia in the first 72 hours of monitoring.
Participant milestones
| Measure |
External Loop Recorder (Single Arm)
This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder) After enrollment in the study the following visits are scheduled:
* Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.
* Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.
* 12-month follow-up visit: In office visit, health status questionnaire
* Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up).
|
|---|---|
|
Overall Study
STARTED
|
250
|
|
Overall Study
COMPLETED
|
233
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
External Loop Recorder (Single Arm)
This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder) After enrollment in the study the following visits are scheduled:
* Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.
* Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.
* 12-month follow-up visit: In office visit, health status questionnaire
* Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up).
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
1 patient was excluded due to LVEF \>35% which is the exclusion criteria
Baseline characteristics by cohort
| Measure |
External Loop Recorder (Single Arm)
n=250 Participants
This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder)
After enrollment in the study the following visits are scheduled:
* Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.
* Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.
* 12-month follow-up visit: In office visit, health status questionnaire
* Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=249 Participants • 1 patient was excluded due to LVEF \>35% which is the exclusion criteria
|
|
Age, Categorical
Between 18 and 65 years
|
192 Participants
n=249 Participants • 1 patient was excluded due to LVEF \>35% which is the exclusion criteria
|
|
Age, Categorical
>=65 years
|
57 Participants
n=249 Participants • 1 patient was excluded due to LVEF \>35% which is the exclusion criteria
|
|
Age, Continuous
|
56 Years
STANDARD_DEVIATION 12 • n=250 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=249 Participants • one patient was excluded due to LVEF\>35 which is the exclusion criteria
|
|
Sex: Female, Male
Male
|
215 Participants
n=249 Participants • one patient was excluded due to LVEF\>35 which is the exclusion criteria
|
|
Region of Enrollment
India
|
250 participants
n=250 Participants
|
|
Ejection Fraction
|
31.7 % Ejection Fraction
STANDARD_DEVIATION 5.8 • n=249 Participants • The baseline cohort consists of 249 patients and the analysis cohort of 233.
|
PRIMARY outcome
Timeframe: 7 days post dischargePost MI mortality is higher in India than in the US and Western Europe. The hypothesis of the INSPIRE-ELR study was that occurrence of arrhythmias in the acute phase of MI will identify patients at highest risk and we evaluated the percentage clinical signification arrhythmias captured through the ELR post MI in acute phase
Outcome measures
| Measure |
External Loop Recorder (Single Arm)
n=233 Participants
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
|
Acute Phase (Without Arrhythmias)
Patients were classified as "without significant arrhythmia" when during the ELR monitoring period and mortality was seen during 12 month follow-up.
|
|---|---|---|
|
The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI
|
48.5 percentage of analyzed population
Interval 42.2 to 54.9
|
—
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: There were total 28 deaths reported
Analysis included all patients that completed the acute monitoring period. Based on the arrhythmias detected during the acute ELR monitoring period, patients were classified as "with arrhythmia" when during the ELR monitoring period there is any episode of ELR monitored events listed. All other patients are classified "without arrhythmia". Mortality rates after the monitoring period was estimated for both groups.
Outcome measures
| Measure |
External Loop Recorder (Single Arm)
n=113 Participants
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
|
Acute Phase (Without Arrhythmias)
n=120 Participants
Patients were classified as "without significant arrhythmia" when during the ELR monitoring period and mortality was seen during 12 month follow-up.
|
|---|---|---|
|
Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year
|
19.6 percentage of Mortality
Interval 13.3 to 28.2
|
3.5 percentage of Mortality
Interval 1.3 to 9.0
|
Adverse Events
External Loop Recorder (Single Arm)
Serious events: 49 serious events
Other events: 0 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
External Loop Recorder (Single Arm)
n=249 participants at risk
For this study, only Deaths and Cardiovascular Related Serious Adverse Events were collected. There were in total 28 deaths and 49 SAEs reported. No system or procedure related SAE were reported
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.6%
4/249 • Number of events 4 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Acute left ventricular failure
|
1.2%
3/249 • Number of events 3 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
3/249 • Number of events 3 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
3/249 • Number of events 3 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Acute myocardial infarction
|
0.80%
2/249 • Number of events 2 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
1.2%
3/249 • Number of events 3 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
3/249 • Number of events 3 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Angina unstable
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Atrioventricular block complete
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Cardiac failure
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Cardiac failure acute
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Cardiac disorders
Left ventricular failure
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
General disorders
Death
|
2.0%
5/249 • Number of events 5 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
General disorders
Unevaluable event
|
0.80%
2/249 • Number of events 2 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
General disorders
Chest discomfort
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
General disorders
Multi-organ failure
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
General disorders
Sudden cardiac death
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
General disorders
Vascular stent restenosis
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Nervous system disorders
Cerebral infarction
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
2/249 • Number of events 2 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
|
Respiratory, thoracic and mediastinal disorders
Aortic stenosis
|
0.40%
1/249 • Number of events 1 • All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place