Mental Stress Reactivity in Women With CMD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45+
SponsorEmory University

About this trial

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.

Eligibility criteria

Qualifiers

Symptomatic postmenopausal women with chest pain

age≥45 years old

willing to undergo cardiac MIBG scan

willing to undergo mental stress testing

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Study Procedures

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator