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Mental Stress Reactivity in Women With CMD
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.
Conditions:
🦠 Post-menopause
🗓️ Study Start (Actual) 19 July 2022
🗓️ Primary Completion (Estimated) 30 September 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

  • CMD Group

    • Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
    • * Severe uncontrolled hypertension \>180/100
    • * Unable to lie flat for mental stress testing
    • * Pre-menopausal
    • * Pregnant
    • * Pericarditis/myocarditis
    • * History of percutaneous coronary intervention
    • * Coronary artery bypass grafting
    • * Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
    • * Significant valvular disease, including aortic or mitral stenosis
    • * Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
    • * Severe lung, renal, liver, or psychiatric illness
    • * Current neoplasm
    • * History of substance abuse
    • * Acute illness such as infection in the previous 4 weeks
    • * Life-expectancy less than 2 years
    • * Unable to safely withdraw medications for mental stress testing
    • * Significant psychiatric illness that precludes safe participation in the study
    • * Conditions that preclude accurate or safe testing and patient refusal
    • * Unable to consent
    • Obstructive CAD (oCAD) Group

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
    • * Severe uncontrolled hypertension \>180/100
    • * Unable to lie flat for mental stress testing
    • * Pre-menopausal
    • * Pregnant
    • * Pericarditis/myocarditis
    • * History of percutaneous coronary intervention
    • * Coronary artery bypass grafting
    • * Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
    • * Significant valvular disease, including aortic or mitral stenosis
    • * Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
    • * Severe lung, renal, liver, or psychiatric illness
    • * Current neoplasm
    • * History of substance abuse
    • * Acute illness such as infection in the previous 4 weeks
    • * Life-expectancy less than 2 years
    • * Unable to safely withdraw medications for mental stress testing
    • * Significant psychiatric illness that precludes safe participation in the study
    • * Conditions that preclude accurate or safe testing and patient refusal
    • * Unable to consent
    • Asymptomatic Control Group

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
    • * Severe uncontrolled hypertension \>180/100
    • * Unable to lie flat for mental stress testing
    • * Pre-menopausal
    • * Pregnant
    • * Pericarditis/myocarditis
    • * History of percutaneous coronary intervention
    • * Coronary artery bypass grafting
    • * Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
    • * Significant valvular disease, including aortic or mitral stenosis
    • * Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
    • * Severe lung, renal, liver, or psychiatric illness
    • * Current neoplasm
    • * History of substance abuse
    • * Acute illness such as infection in the previous 4 weeks
    • * Life-expectancy less than 2 years
    • * Unable to safely withdraw medications for mental stress testing
    • * Significant psychiatric illness that precludes safe participation in the study
    • * Orthopedic limitation that will prevent ETT
    • * LDL \>120 mg/dL
    • * Fasting blood glucose \>95 mg/dL
    • * Hypertension, defined as resting BP \>120/80
    • * Diabetes
    • * Hyperlipidemia
    • * Smoking
    • * Conditions that preclude accurate or safe testing and patient refusal
    • * Unable to consent
Ages Eligible for Study: 45 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 10 May 2022
  • First Submitted that Met QC Criteria 27 May 2022
  • First Posted 2 June 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 December 2023
  • Last Update Posted 12 December 2023
  • Last Verified December 2023
I'm interested ...!!