Trial Outcomes & Findings for Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis (NCT NCT04123197)
NCT ID: NCT04123197
Last Updated: 2026-07-24
Results Overview
The main outcome was a composite endpoint of recurrent MI, unstable angina, hospitalization for decompensated heart failure, and cardiovascular (CV) death. A mental stress-induced myocardial ischemia (MSI) status of positive or negative was used as the main predictor in regression models.
COMPLETED
NA
306 participants
3 Years
2026-07-24
Participant Flow
Participants were recruited from Grady and Emory Healthcare System in Atlanta, Georgia, USA. Participant enrollment began February 28, 2020, and all follow-up was complete by May 31, 2025.
Participants were followed for 3 years with phone calls and review of medical records and the National Death Index, to assess the occurrence of outcome events (a composite endpoint or recurrent MI, unstable angina, hospitalization for decompensated heart failure, and cardiovascular death).
Participant milestones
| Measure |
Young Participants With Prior MI
Participants aged 60 or less who experienced a MI within the last 8 months will undergo a stress challenge to assess MSI and will then be followed for 3 years.
Stress Challenge: The stress challenge will assess how different parts of the body react to stress. Participants will be given no specific details about the contents of the test before administration.
|
|---|---|
|
Overall Study
STARTED
|
306
|
|
Overall Study
COMPLETED
|
296
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Young Participants With Prior MI
Participants aged 60 or less who experienced a MI within the last 8 months will undergo a stress challenge to assess MSI and will then be followed for 3 years.
Stress Challenge: The stress challenge will assess how different parts of the body react to stress. Participants will be given no specific details about the contents of the test before administration.
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Missing information for one partcipant.
Baseline characteristics by cohort
| Measure |
Young Participants With Prior MI
n=306 Participants
Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years.
Stress Challenge: The stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=306 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
306 Participants
n=306 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=306 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 7 • n=306 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=306 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
294 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Black or African American
|
164 Participants
n=306 Participants
|
|
Race (NIH/OMB)
White
|
118 Participants
n=306 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=306 Participants
|
|
Region of Enrollment
United States
|
306 participants
n=306 Participants
|
|
Body Mass Index (BMI)
|
31 Kg/m^2
STANDARD_DEVIATION 6 • n=306 Participants
|
|
Left-ventricular ejection fraction (%)
|
50 percentage of blood pumped
STANDARD_DEVIATION 12 • n=306 Participants
|
|
Education >12 years
|
207 Participants
n=306 Participants
|
|
Income < $25,0000
|
74 Participants
n=305 Participants • Missing information for one partcipant.
|
|
Participants who have a history of smoking
|
124 Participants
n=305 Participants • This information was missing for one participant.
|
PRIMARY outcome
Timeframe: 3 YearsPopulation: The analysis population includes all participants who completed the stress challenge and the study visits.
The main outcome was a composite endpoint of recurrent MI, unstable angina, hospitalization for decompensated heart failure, and cardiovascular (CV) death. A mental stress-induced myocardial ischemia (MSI) status of positive or negative was used as the main predictor in regression models.
Outcome measures
| Measure |
Young Participants With Prior MI
n=292 Participants
Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years.
Stress Challenge: The stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration.
|
|---|---|
|
Cardiovascular Events
MSI Negative · Cardiovascular events
|
60 Participants
|
|
Cardiovascular Events
MSI Positive · Cardiovascular events
|
11 Participants
|
|
Cardiovascular Events
MSI Positive · No cardiovascular events
|
35 Participants
|
|
Cardiovascular Events
MSI Negative · No cardiovascular events
|
186 Participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Results include all participants who completed all study visits and are presented as counts of those who experienced a cardiovascular event versus those who did not. The number of participants who experienced a myocardial infarction or CV death in relation to their MSI status.
The number of participants experiencing myocardial infarction or CV death in relation to MSI status (positive or negative).
Outcome measures
| Measure |
Young Participants With Prior MI
n=292 Participants
Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years.
Stress Challenge: The stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration.
|
|---|---|
|
Myocardial Infarction or Cardiovascular Death
MSI Positive · Myocardial Infarction or Cardiovascular Death
|
5 Participants
|
|
Myocardial Infarction or Cardiovascular Death
MSI Positive · No Myocardial Infarction or Cardiovascular Death
|
41 Participants
|
|
Myocardial Infarction or Cardiovascular Death
MSI Negative · Myocardial Infarction or Cardiovascular Death
|
13 Participants
|
|
Myocardial Infarction or Cardiovascular Death
MSI Negative · No Myocardial Infarction or Cardiovascular Death
|
233 Participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Results include all participants who completed all study visits and are presented as counts of participants who experienced a cardiovascular death and their MSI status.
The number of participants with a CV death in relation to MSI status (positive or negative).
Outcome measures
| Measure |
Young Participants With Prior MI
n=292 Participants
Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years.
Stress Challenge: The stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration.
|
|---|---|
|
Cardiovascular Death
MSI Positive · Cardiovascular death
|
0 Participants
|
|
Cardiovascular Death
MSI Positive · No Cardiovascular death
|
46 Participants
|
|
Cardiovascular Death
MSI Negative · Cardiovascular death
|
4 Participants
|
|
Cardiovascular Death
MSI Negative · No Cardiovascular death
|
242 Participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Mortality was assessed among participants who completed the stress challenge and all study visits. One participant's death was reported in the participant flow but was not included in this outcome analysis due to missing MSI information. The number of participants included in the mortality analysis by MSI status was as follows: MSI-positive (n = 46) and MSI-negative (n = 246).
All-cause death in relation to MSI status (positive or negative).
Outcome measures
| Measure |
Young Participants With Prior MI
n=292 Participants
Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years.
Stress Challenge: The stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration.
|
|---|---|
|
Total Mortality
MSI Positive · All-cause death
|
0 Participants
|
|
Total Mortality
MSI Positive · No mortality
|
46 Participants
|
|
Total Mortality
MSI Negative · All-cause death
|
5 Participants
|
|
Total Mortality
MSI Negative · No mortality
|
241 Participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Results include all participants who completed all study visits and are presented as the number of participants, stratified by MSI status, who experienced a cardiovascular event versus no event.
This is a composite endpoint of recurrent MI, unstable angina, or CV death, where the number of participants experiencing this endpoint in relation to MSI status (positive or negative) was examined.
Outcome measures
| Measure |
Young Participants With Prior MI
n=292 Participants
Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years.
Stress Challenge: The stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration.
|
|---|---|
|
Cardiovascular Events Excluding Heart Failure
MSI Positive · Cardiovascular Events Excluding Heart Failure
|
9 Participants
|
|
Cardiovascular Events Excluding Heart Failure
MSI Positive · No events
|
37 Participants
|
|
Cardiovascular Events Excluding Heart Failure
MSI Negative · Cardiovascular Events Excluding Heart Failure
|
47 Participants
|
|
Cardiovascular Events Excluding Heart Failure
MSI Negative · No events
|
199 Participants
|
Adverse Events
Young Participants With Prior MI
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