Status:
COMPLETED
Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this study is to look at the link between emotional stress and heart disease in men and women. Taking part in this study involves one clinic visit, one week of at home monitoring, and f...
Detailed Description
In the U.S. and globally, coronary heart disease (CHD) is the number one killer of women. Despite scientific advances, it is unclear whether the pathophysiology of CHD differs between women and men. T...
Eligibility Criteria
Inclusion
- History of documented MI within the past 8 months
- Age ≤60 at the time of MI
Exclusion
- History of unstable angina, MI, or decompensated heart failure in the past month
- Patients deemed to be unsafe to hold anti-ischemic medications before testing (it is standard protocol to hold these meds before imaging studies)
- Systolic blood pressure (SBP) \>180 mm Hg or diastolic blood pressure (DBP) \>110 mm Hg on the day of the test
- Alcohol or substance abuse (past year), or severe psychiatric disorder other than major depression
- Other serious medical disorders that may interfere with the study results
- Postmenopausal hormone therapy (past 3 months)
- Current psychotropic medications (past month) except anti-depressants
- Pregnancy or breastfeeding (all women will receive a pregnancy test)
- Severe aortic stenosis
- Weight ≥ 360 pounds and/or body mass index (BMI) of 40 or greater (weight limit of the SPECT imaging table)
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT04123197
Start Date
February 28 2020
End Date
May 31 2025
Last Update
August 12 2025
Active Locations (3)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
Grady Health System
Atlanta, Georgia, United States, 30322
3
The Emory Clinic
Atlanta, Georgia, United States, 30322