Trial Outcomes & Findings for PCI Alternative Using Sustained Exercise (NCT NCT03520400)
NCT ID: NCT03520400
Last Updated: 2024-02-02
Results Overview
Measurement of myocardial blood flow has only been analyzed at baseline at this time. Intravenous 13NH3 will be used as the flow tracer and serial imaging with PET will be performed. Measurements will be performed at baseline, and after pharmacologic stress with dipyridamole. Myocardial blood flow at rest and following dipyridamole infusion will be expressed as ml flow/100 g/min. The myocardial perfusion reserve will be calculated as the ratio of the myocardial blood flow during stress (e.g. after dipyridamole) and the myocardial blood flow at rest. Commercially available software (Emory tool box) will be used to quantitatively analyze PET myocardial perfusion images.
COMPLETED
NA
51 participants
baseline and 1 year
2024-02-02
Participant Flow
Participant milestones
| Measure |
Exercise Intervention Group
Group receives one year of exercise and lifestyle intervention
Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week.
|
PCI Group (Usual Care)
Group receives standard clinical care with no intervention
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
14
|
|
Overall Study
COMPLETED
|
22
|
7
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
Reasons for withdrawal
| Measure |
Exercise Intervention Group
Group receives one year of exercise and lifestyle intervention
Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week.
|
PCI Group (Usual Care)
Group receives standard clinical care with no intervention
|
|---|---|---|
|
Overall Study
Physician Decision
|
15
|
7
|
Baseline Characteristics
PCI Alternative Using Sustained Exercise
Baseline characteristics by cohort
| Measure |
Exercise Intervention Group
n=22 Participants
Group receives one year of exercise and lifestyle intervention
Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week.
|
PCI Group (Usual Care)
n=7 Participants
Group receives standard clinical care with no intervention
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 3.8 • n=99 Participants
|
69.0 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
67.4 years
STANDARD_DEVIATION 4.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 yearPopulation: Patients undergoing angiography for detection of coronary artery disease.
Measurement of myocardial blood flow has only been analyzed at baseline at this time. Intravenous 13NH3 will be used as the flow tracer and serial imaging with PET will be performed. Measurements will be performed at baseline, and after pharmacologic stress with dipyridamole. Myocardial blood flow at rest and following dipyridamole infusion will be expressed as ml flow/100 g/min. The myocardial perfusion reserve will be calculated as the ratio of the myocardial blood flow during stress (e.g. after dipyridamole) and the myocardial blood flow at rest. Commercially available software (Emory tool box) will be used to quantitatively analyze PET myocardial perfusion images.
Outcome measures
| Measure |
Exercise Intervention Group
n=22 Participants
Group receives one year of exercise and lifestyle intervention
Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week.
|
PCI Group (Usual Care)
n=7 Participants
Group receives standard clinical care with no intervention
|
|---|---|---|
|
Myocardial Perfusion Reserve
Baseline
|
2.76 Ratio
Standard Deviation 0.61
|
2.47 Ratio
Standard Deviation 0.48
|
|
Myocardial Perfusion Reserve
1-year
|
2.82 Ratio
Standard Deviation 0.56
|
2.52 Ratio
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: baseline and after 1 yearPopulation: Subjects undergoing angiography for detection of coronary artery disease.
Peak VO2 will be determined at baseline and 1 year on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses.
Outcome measures
| Measure |
Exercise Intervention Group
n=22 Participants
Group receives one year of exercise and lifestyle intervention
Exercise Therapy: Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week.
|
PCI Group (Usual Care)
n=7 Participants
Group receives standard clinical care with no intervention
|
|---|---|---|
|
Peak VO2
Baseline
|
20.21 ml/kg/min
Standard Deviation 3.76
|
19.85 ml/kg/min
Standard Deviation 6.5
|
|
Peak VO2
1 Year
|
22.4 ml/kg/min
Standard Deviation 4.10
|
18.91 ml/kg/min
Standard Deviation 5.92
|
Adverse Events
Exercise Intervention Group
PCI Group (Usual Care)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place