RecruitingNot Applicable

Mental Stress Reactivity in Women With CMD

United States150 participantsStarted 2022-07-19

Plain-language summary

Coronary Microvascular Dysfunction (CMD) occurs when there are problems in the small blood vessels/arteries of the heart, resulting in persistent chest pain that affects women. There are an estimated 3 million women in the US with CMD and about 100,000 new cases annually. This research will investigate whether the stress response physiology and autonomic function in response to mental stress are different in women with CMD compared to other groups. The autonomic nervous system (ANS) controls normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. This study will also examine how chronic and daily life mental stress affects the heart and blood vessels. Participants from this study will be recruited mainly from Emory Healthcare-associated hospitals, the Emory Heart Disease Center for Prevention, and Emory Healthcare outpatient cardiology clinics. Participants will have physical exams, blood tests, stress tests, exercise tests, surveys, questionnaires, and images taken of their hearts and blood vessels. They will be asked to take home devices to monitor their autonomic function, sleep, and track their mood, stress level, and symptoms for one week. Data and specimens will be saved for future research.

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) G…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Planar late Heart to Mediastinal Ratio (MIBG imaging)

Timeframe: At the end of MIBG procedure

Changes in HRV with mental stress

Timeframe: Baseline (prior to stress testing) and during mental stress test

Changes in pre-ejection period (PEP) with mental stress

Timeframe: Baseline (prior to stress testing) and during mental stress test

Trial details

NCT IDNCT05401630

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Puja K Mehta, MD

404-712-0281 pkmehta@emory.edu

View on ClinicalTrials.gov More Post-menopause trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Planar late Heart to Mediastinal Ratio (MIBG imaging)

Timeframe: At the end of MIBG procedure

Changes in HRV with mental stress

Timeframe: Baseline (prior to stress testing) and during mental stress test

Changes in pre-ejection period (PEP) with mental stress

Timeframe: Baseline (prior to stress testing) and during mental stress test