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Stress Response Study for Heart Issues

N/A

Recruiting

Led By Puja K Mehta

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteer with no cardiac risk factors

No history or diagnosis of heart disease

Must not have

Severe uncontrolled hypertension >180/100

Significant anemia or blood dyscrasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trialaims to investigate the stress response of women with Coronary Microvascular Dysfunction (CMD) and how it affects their heart, blood vessels, and autonomic nervous system.

Who is the study for?

This trial is for women over 50 with menopause-related chest pain and Coronary Microvascular Dysfunction (CMD), who can consent to tests. They must be willing to undergo a cardiac scan, mental stress testing, and have no acute illnesses or diabetes. Excluded are those with severe heart issues, uncontrolled hypertension, recent heart attacks, certain blood conditions, or significant artery blockages.

What is being tested?

The study investigates how mental stress affects the autonomic function in postmenopausal women with CMD compared to others. It involves physical exams, blood tests, imaging of the heart and vessels, plus home monitoring of autonomic function and daily stress levels for one week.

What are the potential side effects?

Since this trial focuses on non-invasive procedures like scans and monitoring rather than medication or surgical interventions, side effects may include discomfort from exercise tests or anxiety during mental stress testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy with no heart disease risk factors.

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I have never been diagnosed with heart disease.

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I understand the information given to me and can make decisions about my health care.

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I am 50 years old or older.

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I am a postmenopausal woman experiencing chest pain.

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I am willing to have a heart scan.

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I am not taking any heart medications.

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I am a woman over 50 and have gone through menopause without symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not higher than 180/100.

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I have a serious blood disorder or significant anemia.

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My heart pumps well but is not functioning properly.

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I have not had a heart attack or severe heart issues in the last month.

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I cannot safely stop my mental health medications for a test.

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I have a serious heart valve problem.

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I currently have a tumor.

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I have a major blockage in one of my heart's arteries.

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I have a bone or joint problem that stops me from doing an exercise test.

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I do not have severe lung, kidney, liver, or mental health issues.

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I have not gone through menopause.

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I have inflammation of the heart or its surrounding tissues.

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My heart's pumping ability is reduced.

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I have had heart bypass surgery.

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I have had a procedure to open blocked arteries in my heart.

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I cannot lie flat for tests due to discomfort or other reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in HRV with mental stress

Changes in pre-ejection period (PEP) with mental stress

Planar late Heart to Mediastinal Ratio (MIBG imaging)

Secondary study objectives

Changes in Peripheral arterial tonometry (PAT) test to acute mental stress in CMD women.

Changes in flow mediated dilation (FMD test) to acute mental stress in CMD women.

Examine whether chronic stress burden and autonomic dysfunction during daily life is elevated in CMD women.

Other study objectives

Assessment of general health status

Assessment of quality of life and relationship to anginal symptoms

Changes in catecholamines (norepinephrine and epinephrine) with mental stress among the three groups.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Symptomatic women with no obstructive CAD who have CMDExperimental Treatment1 Intervention

Symptomatic women with chest pain and no obstructive CAD who have an abnormal myocardial flow reserve (MFR \< 2.5)

Group II: Symptomatic women with chronic obstructive CAD (oCAD)Experimental Treatment1 Intervention

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.

Group III: Asymptomatic control women with no prior history of CAD or anginaActive Control1 Intervention

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.

0 / 24Eligibility criteria met