RECRUITING

Mental Stress Reactivity in Women With CMD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction

Quick Facts

Study Start:2022-07-19
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05401630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Symptomatic postmenopausal women with chest pain
  2. * age≥45 years old
  3. * willing to undergo cardiac MIBG scan
  4. * willing to undergo mental stress testing
  5. * competent to give informed consent
  1. * Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
  2. * Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
  3. * Heart failure with a preserved ejection fraction
  4. * Significant anemia or blood dyscrasia
  5. * Severe uncontrolled hypertension \>180/100
  6. * Unable to lie flat for mental stress testing
  7. * Pre-menopausal
  8. * Pregnant
  9. * Pericarditis/myocarditis
  10. * History of percutaneous coronary intervention
  11. * Coronary artery bypass grafting
  12. * Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
  13. * Significant valvular disease, including aortic or mitral stenosis
  14. * Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
  15. * Severe lung, renal, liver, or psychiatric illness
  16. * Current neoplasm
  17. * History of substance abuse
  18. * Acute illness such as infection in the previous 4 weeks
  19. * Life-expectancy less than 2 years
  20. * Unable to safely withdraw medications for mental stress testing
  21. * Significant psychiatric illness that precludes safe participation in the study
  22. * Conditions that preclude accurate or safe testing and patient refusal
  23. * Unable to consent

Contacts and Locations

Study Contact

Puja K Mehta, MD
CONTACT
404-712-0281
pkmehta@emory.edu
Puja K Mehta, MD
CONTACT

Principal Investigator

Puja K Mehta
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
United States
Emory Clinic
Atlanta, Georgia, 30322
United States
Emory Hospital
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Puja K Mehta, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-19
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-07-19
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Microvascular
  • Sympathetic activity
  • Mental Stress
  • Angina

Additional Relevant MeSH Terms

  • Post-menopause