Mental Stress Reactivity in Women With CMD

Conditions

• Post-menopause

Eligibility Criteria

Sex

FEMALE

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Study Procedures — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jul 19, 2022

Status verified

Jan 2026

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

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.

Primary Outcome Measure

Planar late Heart to Mediastinal Ratio (MIBG imaging) [ Time Frame: At the end of MIBG procedure ]

Central Contacts

• Puja K Mehta, MD
  404-712-0281
  [email protected]
• Puja K Mehta, MD

Locations (4)

Find similar trials in Atlanta, GA

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