NCT00573027 Heart Disease of the Small Arteries in Women and Men

Eligibility & Interventions

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This trial targets 634 participants in total. It began in 2005-11 with a primary completion date of 2040-01.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. 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 2. No obstructive coronary artery disease performed within the previous 24 months (\<50% luminal obstruction in one or more coronary arteries on angiography). 3. Age \> 18 years old 4. Competent to give informed consent Exclusion Criteria: 1. Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery, 2. Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000), 3. Primary valvular heart disease clearly indicating the need for valve repair or replacement; 4. Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support; 5. Prior or planned percutaneous coronary intervention or CABG or prior acute MI in prior 30 days; 6. Prior non-cardiac illness with an estimated life expectancy \<4 years; 7. Unable to give informed consent; 8. Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm); 9. Contraindications to adenosine or Regadenoson (Lexiscan) 10. 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. 11. Heart failure (NYHA Class III or IV on treatment) 12. LV dysfunction (ejection fraction \<40%) 13. Documented obstructive myocardiopathy

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