NCT05401630 Mental Stress Reactivity in Women With CMD
| NCT ID | NCT05401630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Post-menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-07-19 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2022-07-19 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Puja K Mehta
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05401630 clinical trial?
This trial is open to female participants only, aged 45 Years or older, studying Post-menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05401630 currently recruiting?
Yes, NCT05401630 is actively recruiting participants. Contact the research team at pkmehta@emory.edu for enrollment information.
Where is the NCT05401630 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT05401630 clinical trial?
NCT05401630 is sponsored by Emory University. The principal investigator is Puja K Mehta at Emory University. The trial plans to enroll 150 participants.