NCT05401630Recruiting
Mental Stress Reactivity in Women With CMD
Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 May 2022
- Start date
- 19 Jul 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- Emory University
- Diseases
- Coronary artery disease
- NCT number
- NCT05401630
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 19 Jul 2022 to the primary completion date, Dec 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute illness such as infection in the previous 4 weeks
- Unable to safely withdraw medications for mental stress testing
- Acute illness such as infection in the previous 4 weeks
- Unable to safely withdraw medications for mental stress testing
- Acute illness such as infection in the previous 4 weeks
- Unable to safely withdraw medications for mental stress testing
Other illness
- Severe uncontrolled hypertension \>180/100
- History of percutaneous coronary intervention
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Severe lung, renal, liver, or psychiatric illness
- History of substance abuse
- Significant psychiatric illness that precludes safe participation in the study
- Conditions that preclude accurate or safe testing and patient refusal
- Severe uncontrolled hypertension \>180/100
- History of percutaneous coronary intervention
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Severe lung, renal, liver, or psychiatric illness
- History of substance abuse
- Significant psychiatric illness that precludes safe participation in the study
- Conditions that preclude accurate or safe testing and patient refusal
- Severe uncontrolled hypertension \>180/100
- History of percutaneous coronary intervention
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Severe lung, renal, liver, or psychiatric illness
- History of substance abuse
- Significant psychiatric illness that precludes safe participation in the study
- Hypertension, defined as resting BP \>120/80
- Diabetes
- Conditions that preclude accurate or safe testing and patient refusal
Lab values
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- LDL \>120 mg/dL
- Fasting blood glucose \>95 mg/dL
Other
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Significant anemia or blood dyscrasia
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- Coronary artery bypass grafting
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Current neoplasm
- Life-expectancy less than 2 years
- Unable to consent
- Obstructive CAD (oCAD) Group
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Significant anemia or blood dyscrasia
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- Coronary artery bypass grafting
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Current neoplasm
- Life expectancy is less than 2 years
- Unable to consent
- Asymptomatic Control Group
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Significant anemia or blood dyscrasia
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- Coronary artery bypass grafting
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Current neoplasm
- Life expectancy is less than 2 years
- Orthopedic limitation that will prevent ETT
- Hyperlipidemia
- Smoking
- Unable to consent
Who the study is looking for
- 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
- 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
- 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
Criteria the registry did not label
- CMD Group
Age in the registry: 45 years to - · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Clinic Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.