Status:
RECRUITING
Mental Stress Reactivity in Women With CMD
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Post-menopause
Eligibility:
FEMALE
45+ years
Phase:
NA
Brief Summary
Coronary Microvascular Dysfunction (CMD) occurs when there are problems in small blood vessels/arteries in the heart and symptoms of persistent chest pain that impact women. There are an estimated 3 ...
Detailed Description
The overall goal of this project is to clarify the mechanisms and pathophysiology of how psychological stress contributes to Major Adverse Cardiovascular Events (MACE) in women despite having no obstr...
Eligibility Criteria
Inclusion
- CMD Group
- Symptomatic postmenopausal women with chest pain
- age≥50 years old
- willing to undergo cardiac MIBG scan
- willing to undergo mental stress testing
- competent to give informed consent
Exclusion
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Significant anemia or blood dyscrasia
- Severe uncontrolled hypertension \>180/100
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- History of percutaneous coronary intervention
- Coronary artery bypass grafting
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Severe lung, renal, liver, or psychiatric illness
- Current neoplasm
- History of substance abuse
- Acute illness such as infection in the previous 4 weeks
- Life-expectancy less than 2 years
- Unable to safely withdraw medications for mental stress testing
- Significant psychiatric illness that precludes safe participation in the study
- Conditions that preclude accurate or safe testing and patient refusal
- Unable to consent
- Obstructive CAD (oCAD) Group
- Inclusion Criteria:
- Symptomatic postmenopausal women with chest pain who have obstructive CAD in at least one epicardial coronary artery
- willing to undergo cardiac MIBG scan
- willing to undergo mental stress testing
- competent to give informed consent
Key Trial Info
Start Date :
July 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05401630
Start Date
July 19 2022
End Date
December 31 2026
Last Update
January 20 2025
Active Locations (4)
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1
Emory Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30308
3
Emory Clinic
Atlanta, Georgia, United States, 30322
4
Emory Hospital
Atlanta, Georgia, United States, 30322