NCT05401630 · Emory University
Mental Stress Reactivity in Women With CMD
What this study is about
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.
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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.
Interventions
OTHER
Study Procedures
All participants will answer a series of questionnaires that address several factors such as patient medical history, family history, medication usage, health behaviors, psychological factors, etc. Questionnaires related to symptoms, psychological factors, depression, anxiety, and quality of life will be taken. All participants will undergo 123I-MIBG SPECT imaging in the morning in a fasting state. Mental Stress Testing will be conducted in the Laboratory in the morning after fasting for at least 4 hours and withdrawal of all vasoactive medications, caffeine, and tobacco 24-48 hours before testing. Participants will also undergo 1-week of Home Monitoring using a single-use, noninvasive, water-resistant, 7-day ambulatory ECG monitoring, which offers the advantage of direct access to raw data that can be downloaded from the device after use. A 3-day food recall diary, cognitive assessments via the NIH Toolbox, and a Sleep diary during home monitoring will be collected.
Primary outcome measures
Planar late Heart to Mediastinal Ratio (MIBG imaging)
Time frame: At the end of MIBG procedure
The research team will compare resting sympathetic activity measured with 123I-meta-iodobenzylguanidine (MIBG) imaging between CMD women and the two control groups. The heart to the mediastinal ratio (HMR) which is an index of MIBG uptake will be calculated as per standard methods. The HMR reflects norepinephrine kinetics. Higher sympathetic activity and turnover cause less MIBG to be retained and result in a lower HMR. MIBG SPECT defect score will be determined by late (4 hours) MIBG uptake by visual blind scoring using the standard 17-segment model with 0=normal tracer uptake, 1=mildly reduced uptake, 2=moderately reduced uptake, 3=severely reduced uptake, 4=absent tracer uptake, as defined by Bax et al.
Changes in HRV with mental stress
Time frame: Baseline (prior to stress testing) and during mental stress test
The research team will also compare autonomic reactivity during a standardized mental stress test, including heart rate variability (HRV) between CMD women and the two control groups
Changes in pre-ejection period (PEP) with mental stress
Time frame: Baseline (prior to stress testing) and during mental stress test
The research team will also compare autonomic reactivity during a standardized mental stress test, including the pre-ejection period (PEP) between CMD women and the two control groups. This measures systolic time interval and reflects cardiac contractility (which is under the beta-adrenergic influence). Impedance ECG measures PEP from the onset of ventricular depolarization (Q-wave on ECG) to the opening of the aortic valve for ejection of blood from the left ventricle.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
- 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
- Hyperlipidemia
- Conditions that preclude accurate or safe testing and patient refusal
- Unable to consent
Where
- Atlanta, Georgia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations