Mental Stress Reactivity in Women With CMD

What this trial studies

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.

Conditions in scope

• Post-menopause

Interventions

• Study Procedures (Other) — All participants will answer a series of questionnaires that address several factors such as patient medical history, family history, medication usage, health behaviors, psychological factors, etc. Questionnaires related to symptoms, psychological factors, depression, anxiety, and quality of life will be…

Who can join

Women only · Ages 45 Years and up

Inclusion criteria

• CMD Group
• Symptomatic postmenopausal women with chest pain
• age≥45 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
• Asymptomatic postmenopausal women, age ≥ 45 years old

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2022-07-19
• Primary completion: 2026-09-30
• Last update posted: 2026-01-29
• First posted: 2022-06-02

Sponsor & contact

Lead sponsor: Emory University (Other)

Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Planar late Heart to Mediastinal Ratio (MIBG imaging) (At the end of MIBG procedure)
  The research team will compare resting sympathetic activity measured with 123I-meta-iodobenzylguanidine (MIBG) imaging between CMD women and the two control groups. The heart to the mediastinal ratio (HMR) which is an index of MIBG uptake will be calculated as per standard methods. The HMR reflects norepinephrine kinetics. Higher sympathetic activity and turnover cause less MIBG to be retained and result…
• Changes in HRV with mental stress (Baseline (prior to stress testing) and during mental stress test)
  The research team will also compare autonomic reactivity during a standardized mental stress test, including heart rate variability (HRV) between CMD women and the two control groups
• Changes in pre-ejection period (PEP) with mental stress (Baseline (prior to stress testing) and during mental stress test)
  The research team will also compare autonomic reactivity during a standardized mental stress test, including the pre-ejection period (PEP) between CMD women and the two control groups. This measures systolic time interval and reflects cardiac contractility (which is under the beta-adrenergic influence). Impedance ECG measures PEP from the onset of ventricular depolarization (Q-wave on ECG) to the opening of the…

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