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Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction (CMD)

This study is looking at how mental stress affects women who have Coronary Microvascular Dysfunction (CMD). CMD is a condition where small blood vessels in the heart don't work properly, causing chest pain, often in women after menopause. Researchers want to understand if the body's response to stress is different in women with CMD and how daily stress impacts their heart and blood vessels. You would answer questionnaires about your health, lifestyle, and feelings. The study will measure changes in your heart rate variability (HRV) and pre-ejection period (PEP) during mental stress tests, and also use MIBG imaging to look at your heart. The goal is to better understand the link between mental stress and heart problems in women with CMD. This study is for postmenopausal women, aged 45 or older, who experience chest pain and are willing to undergo specific heart tests.

Study design
This is an interventional study with a planned enrollment of 150 postmenopausal women.
What's involved
You would complete a series of questionnaires and undergo mental stress testing, as well as a cardiac MIBG scan.
Compensation
Not stated in the trial record.
Follow-up
Heart to Mediastinal Ratio (MIBG imaging) is measured at the end of the MIBG procedure. Changes in HRV and PEP are measured at baseline and during mental stress testing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05401630

Mental Stress Reactivity in Women With CMD

Recruiting
NAAges 45+InterventionalScreening
Emory University
~150 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:Study Procedures

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Planar late Heart to Mediastinal Ratio (MIBG imaging)
Measured over At the end of MIBG procedure
+2 more outcomes measured

Conditions

Post-menopause

Explore related trials

Coronary Artery DiseaseCoronary microvascular dysfunctionHealthy

Where it's being run

4 sites across 1 states
Georgia4

Study leadership

  • Puja K Mehta · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Puja K Mehta, MD
[email protected]
404-712-0281
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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
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
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

What this trial measures

  • Planar late Heart to Mediastinal Ratio (MIBG imaging)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 stressBaseline (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 stressBaseline (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.