Cardiac Autonomic Function in Women with Microvascular Coronary Dysfunction

Summary

Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous system (ANS) is part of the central nervous system to help people adapt to changes in their environment. It controls what are normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. However, there is a limited understanding of the role of ANS in MCD. This research is proposed to investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac imaging and cardiac autonomic function testing. 100 participants will be recruited in the next five years.

Conditions

• Microvascular Coronary Dysfunction

Interventions

BEHAVIORAL

Mental Stress Testing

Mental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women.

OTHER

Peripheral Arterial Tonometry (PAT) Testing

PAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd).

OTHER

Heart Rate Variability (HRV)

Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours.

OTHER

RESPeRATE Breathing Trial

RESPeRATE Breathing will test whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and will test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress.

PROCEDURE

SPECT cardiac scan with 123I-mIBG and Myoview

Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity.

Sponsors & Collaborators

• Cedars-Sinai Medical Center

  lead OTHER

Principal Investigators

• C. Noel Bairey Merz, M.D. · Cedars-Sinai Medical Center

• Puja Mehta, M.D. · Emory University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2024-02-29

Completion

2024-02-29

Countries

• United States

Study Locations