Investigating mental stress effects on heart health in postmenopausal women
Official title: Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction
Run by Emory University · NCT05401630 · Data updated 2026-11-12
This study is testing how mental stress affects heart health in postmenopausal women who have chest pain but no blocked arteries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years and up |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Status | Recruiting |
| Started | July 19, 2022 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT05401630 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are symptomatic postmenopausal women aged 50 and older who experience chest pain and are willing to participate in cardiac testing.
✕Probably not a fit
Patients with significant coronary artery disease or other serious cardiac conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Vaginal DHEA vs Vaginal Estrogen for Menopause Symptoms
This study tests whether vaginal DHEA or vaginal estrogen helps with vaginal dryness, discomfort, and urinary symptoms in peri- or post-menopausal women by randomly assigning participants to one treatment and measuring their symptoms over time.
-
Beetroot juice to boost the benefits of exercise for postmenopausal women.
This project will test whether taking a daily beetroot juice shot alongside supervised exercise helps postmenopausal women get larger improvements in heart and metabolic health, body composition, strength, and endurance than exercise with a placebo drink.
-
Amylopectin‑chromium supplement and protein balance in peri- and post-menopausal women
This study will test whether taking an amylopectin‑chromium supplement with protein after a short resistance exercise bout helps peri- and post-menopausal women maintain a positive whole‑body protein balance and influences 24‑hour glucose control.
-
Comparing aerobic and resistance exercise in post-menopausal women with type 1 diabetes
This study tests whether aerobic or resistance exercise helps post-menopausal women with type 1 diabetes better manage their blood sugar levels.
-
Hop extract vs soy isoflavone for menopausal symptoms
This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.
-
Resveratrol and Estrogen Receptors in Postmenopausal Women with CAD
This study tests whether taking resveratrol is safe and can change estrogen-related markers in postmenopausal women with coronary artery disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.