Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT05401630

Conditions

Post-menopause

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Study Procedures

Study Details

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.

Conditions

Post-menopause

Study ID

NCT05401630

Start date

Jul 19, 2022

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Symptomatic women with no obstructive CAD who have CMD

Symptomatic women with chest pain and no obstructive CAD who have an abnormal myocardial flow reserve (MFR < 2.5)

experimental: Symptomatic women with chronic obstructive CAD (oCAD)

This group will serve as one comparison group since these women represent the prevailing paradigm of ischemia from obstructive stenosis while sharing common cardiovascular risk factors with the CMD group.

active comparator: Asymptomatic control women with no prior history of CAD or angina

Asymptomatic control women with no prior history of CAD or angina, who are age-matched to the CMD women; not on any cardiac medications, who will also have to pass a maximal Bruce protocol exercise treadmill test.

Interventions

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 measure

  • Planar late Heart to Mediastinal Ratio (MIBG imaging) [ Time Frame: At the end of MIBG procedure ]
  • Changes in HRV with mental stress [ Time Frame: Baseline (prior to stress testing) and during mental stress test ]
  • Changes in pre-ejection period (PEP) with mental stress [ Time Frame: Baseline (prior to stress testing) and during mental stress test ]

Central Contacts and Locations

Central contacts

Puja K Mehta, MD

404-712-0281pkmehta@emory.edu

Locations

Emory Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30308

Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Emory Hospital

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Microvascular
  • Sympathetic activity
  • Mental Stress
  • Angina

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-29.