Actively Recruiting

Phase Not Applicable
Age: 45Years +
FEMALE
NCT05401630

Mental Stress Reactivity in Women With CMD

Led by Emory University · Updated on 2026-01-29

150

Participants Needed

4

Research Sites

232 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Mental Stress Reactivity in Women With CMD

Who Can Participate

Age: 45Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 45 years or older
  • Postmenopausal status
  • Symptomatic women with chest pain (CMD and obstructive CAD groups)
  • Asymptomatic healthy women with no history of heart disease (control group)
  • Willingness to undergo cardiac MIBG scan and mental stress testing
  • Ability to provide informed consent
  • Normal maximal exercise treadmill stress test for control group
  • No cardiac medications for control group
Not Eligible

You will not qualify if you...

  • Significant epicardial coronary artery stenosis (≥70% blockage) or hemodynamically significant stenosis
  • Left ventricular ejection fraction 50% or less
  • Heart failure with preserved ejection fraction
  • Significant anemia or blood disorders
  • Severe uncontrolled high blood pressure (over 180/100)
  • Unable to lie flat for mental stress testing
  • Premenopausal women
  • Pregnancy
  • Pericarditis or myocarditis
  • History of coronary interventions (PCI or bypass surgery)
  • Recent acute heart events within 1 month
  • Significant valve disease (aortic or mitral stenosis)
  • Serious heart rhythm problems or pacemaker
  • Severe lung, kidney, liver, or psychiatric illness
  • Current cancer
  • History of substance abuse
  • Recent acute illness or infection within 4 weeks
  • Life expectancy less than 2 years
  • Unable to safely stop medications for stress testing
  • Significant psychiatric illness preventing safe participation
  • Conditions preventing accurate or safe testing or refusal to participate
  • Unable to consent
  • For control group: orthopedic limitations preventing exercise testing, high LDL cholesterol (>120 mg/dL), high fasting blood glucose (>95 mg/dL), hypertension (>120/80), diabetes, hyperlipidemia, or smoking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Emory Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

2

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30308

Actively Recruiting

3

Emory Clinic

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

Emory Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

Loading map...

Research Team

P

Puja K Mehta, MD

CONTACT

P

Puja K Mehta, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here