Investigating mental stress effects on heart health in postmenopausal women
Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction
This study is testing how mental stress affects heart health in postmenopausal women who have chest pain but no blocked arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT05401630 on ClinicalTrials.gov |
What this trial studies
This research focuses on understanding how mental stress affects coronary microvascular dysfunction (CMD) in postmenopausal women who experience chest pain but do not have obstructive coronary artery disease. The study will assess the physiological stress responses and autonomic function in these women compared to other groups. Participants will undergo various evaluations, including cardiac imaging and mental stress testing, to clarify the relationship between psychological stress and heart health. The goal is to improve the understanding of CMD and its implications for cardiovascular events in women.
Who should consider this trial
Good fit: Ideal candidates are symptomatic postmenopausal women aged 50 and older who experience chest pain and are willing to participate in cardiac testing.
Not a fit: Patients with significant coronary artery disease or other serious cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and treatment strategies for women suffering from CMD, ultimately improving their quality of life and reducing cardiovascular risks.
How similar studies have performed: While there is limited research specifically targeting CMD in women, studies on stress and cardiovascular health have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
CMD Group Inclusion Criteria: * Symptomatic postmenopausal women with chest pain * age≥45 years old * willing to undergo cardiac MIBG scan * willing to undergo mental stress testing * competent to give informed consent Exclusion Criteria: * 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 Exclusion Criteria: * 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 is 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 Asymptomatic Control Group Inclusion Criteria: * Asymptomatic postmenopausal women, age ≥ 45 years old * Healthy volunteer with no cardiac risk factors * No history or diagnosis of heart disease * Not on any cardiac medications * Normal maximal exercise treadmill stress testing (ETT) * Fully understanding and willing to undergo mental stress testing * Willing to sign the informed consent Exclusion Criteria: * 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 is less than 2 years * Unable to safely withdraw medications for mental stress testing * Significant psychiatric illness that precludes safe participation in the study * Orthopedic limitation that will prevent ETT * LDL \>120 mg/dL * Fasting blood glucose \>95 mg/dL * Hypertension, defined as resting BP \>120/80 * Diabetes * Hyperlipidemia * Smoking * Conditions that preclude accurate or safe testing and patient refusal * Unable to consent
Where this trial is running
Atlanta, Georgia and 3 other locations
- Emory Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory Clinic — Atlanta, Georgia, United States (Recruiting)
- Emory Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Puja K Mehta — Emory University
- Study coordinator: Puja K Mehta, MD
- Email: pkmehta@emory.edu
- Phone: 404-712-0281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-06-13 by the Find a Trial editorial team.
Information on this page is for educational purposes and is not medical advice.
Always consult qualified healthcare professionals about clinical trial participation.