Heart Disease of the Small Arteries in Women and Men

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT00573027
Status
Recruiting
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Conditions

  • Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • noninvasive tests — PROCEDURE
    clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory; Peripheral Artery Tonometry (PAT) testing; Cardiac Magnetic Resonance (CMR) imaging.

Study Details

Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to mediate chest pain in this syndrome. This disorder of the small heart vessels (arterioles) compared to the large vessels (arteries) is not diagnosed during routine heart catheterization. This results in delays in diagnosis, missed opportunities for treatment, and likely contributes to the increased death rate from coronary heart disease in women compared to men. Current testing for small vessel disease is performed in the cardiac catheterization laboratory using specialized testing and is not performed routinely. Accordingly, women with this condition are either falsely reassured, or misdiagnosed as another non-cardiac condition. Unnecessary healthcare costs related to re-hospitalization and repeat angiography are incurred, while women are often not initiated on appropriate lifesaving treatment. We and others have demonstrated in randomized controlled trials that therapies that target the endothelium, e.g. statins, ACE inhibitors, and exercise are effective in this condition. Majority of women with Cardiac Syndorme X go undiagnosed. Recent studies have shown significant increased health care costs, morbidity and mortality related to this disease. It is becoming more important to further characterize this group of patients and we hope to do that with our study.

Key Dates

Start date
Nov 30, 2005
Status verified
Aug 2023
Primary completion
Jan 31, 2040
Completion
Jan 31, 2040

Study Design

Enrollment
634 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm
    1. fill out baseline demographic and health/medical history questionnaires, CV risk factors, reasons of diagnosis of ischemia, information of coronary artery, and medication use 2. undergo clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory (Appendix); 3. undergo noninvasive Peripheral Artery Tonometry (PAT) testing (Appendix); 4. undergo clinically indicated Cardiac Magnetic Resonance (CMR) imaging (Appendix) to detect subendocardial ischemia (if indicated and referred by the treating physician). The three tests (heart catheterization with adenosine coronary flow reserve testing, acetylcholine provocative vasomotor testing during heart catheterization, cardiac MRI) are performed for standard care. 5. have blood and urine testing. 6. fill out health questionnaires 7. be followed prospectively 6-week, 6-month, and annually for clinical status

Primary Outcome Measure

noninvasive Peripheral Artery Tonometry (PAT) testing and Cardiac Magnetic Resonance (CMR) imaging for the outcome of coronary endothelial dysfunction [ Time Frame: 120 minutes ]

Central Contacts

  • Barbra Streisand Women's Heart Center
    310-423-9666

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Women's Heart CenterLos AngelesCalifornia90048
Barbra Streisand Women's Heart Center
310-423-9666
Noel Bairey-Merz, MD (PRINCIPAL_INVESTIGATOR)
Saibal Kar, MD (SUB_INVESTIGATOR)
Raj Makkar, MD (SUB_INVESTIGATOR)
Dan Berman, MD (SUB_INVESTIGATOR)
Leslee Shaw, MD (SUB_INVESTIGATOR)
Louise Thompson, MBChB (SUB_INVESTIGATOR)
Rola Saouf, MD (SUB_INVESTIGATOR)

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Cedars-Sinai Women's Heart Center· Los Angeles, CA

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