Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Coronary Microvascular Dysfunction (CMD) occurs when there are problems in small blood vessels/arteries in the heart and symptoms of persistent chest pain that impact 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, 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 to track their mood, stress level, and symptoms for one week. Data and specimens will be saved for future research.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: f
View:

• Symptomatic postmenopausal women with chest pain

• age≥50 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 ≥ 50 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

Locations
United States
Georgia
Emory Clinic
RECRUITING
Atlanta
Emory Hospital
RECRUITING
Atlanta
Emory Hospital Midtown
RECRUITING
Atlanta
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Contact Information
Primary
Puja K Mehta, MD
pkmehta@emory.edu
404-712-0281
Backup
Puja K Mehta, MD
Time Frame
Start Date: 2022-07-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Emory University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov