What this study is
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.
What's being tested
- noninvasive tests
Intervention · 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
- Official title
- Coronary Microvascular Disease and Endothelial Function in Women and Men
- Sponsor
- Cedars-Sinai Medical Center
- Conditions
- Heart Disease
- Enrolling
- 634 people
- Starts
- 2005-11
- Est. completion
- 2040-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Women and men with signs and symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing) or microvascular angina (MVA) which is defined as angina and ischemic ECG changes without organic obstructive stenosis or epicardial spasm of the coronary arteries
- No obstructive coronary artery disease performed within the previous 24 months (<50% luminal obstruction in one or more coronary arteries on angiography).
- Age > 18 years old
- Competent to give informed consent
You can't join if
- Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
- Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000),
- Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior or planned percutaneous coronary intervention or CABG or prior acute MI in prior 30 days;
- Prior non-cardiac illness with an estimated life expectancy <4 years;
- Unable to give informed consent;
- Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
- Contraindications to adenosine or Regadenoson (Lexiscan)
- Women and men with intermediate coronary stenoses (>20% but <50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated IVUS testing based on the judgment of the operator; those determined to have flow FFR or obstructing stenosis will be excluded from the overall study.
- Heart failure (NYHA Class III or IV on treatment)
- LV dysfunction (ejection fraction <40%)
- Documented obstructive myocardiopathy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCedars-Sinai Women's Heart Center
Los Angeles, California, United States
- Barbra Streisand Women's Heart Center · Contact310-423-9666
- 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
Recruiting
Study team
Sponsor
Cedars-Sinai Medical Center
Study ID IRB 8221
Principal investigator
C.Noel Bairey-Merz, MD
Cedars-Sinai Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.