Investigating Heart Disease in Small Arteries in Men and Women

Coronary Microvascular Disease and Endothelial Function in Women and Men

This study is testing new ways to diagnose heart disease in small arteries, especially in women with chest pain who don't have major blockages, to help improve their treatment options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 634 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT00573027 on ClinicalTrials.gov

What this trial studies

This study aims to understand the prevalence of microvascular disease in individuals with Cardiac Syndrome X, particularly focusing on women who experience chest pain without significant blockages in large heart arteries. It will evaluate the effectiveness of noninvasive tests like Peripheral Artery Tonometry and Cardiac Magnetic Resonance in diagnosing this condition. Participants will undergo specialized testing during heart catheterization to assess abnormalities in their small heart arteries, while also providing detailed medical histories through questionnaires. The research seeks to improve diagnosis and treatment options for patients suffering from microvascular angina.

Who should consider this trial

Good fit: Ideal candidates include men and women over 18 years old who exhibit signs of myocardial ischemia or angina without obstructive coronary artery disease.

Not a fit: Patients with significant obstructive coronary artery disease or acute coronary syndrome will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnosis and treatment for patients suffering from microvascular dysfunction, particularly women with Cardiac Syndrome X.

How similar studies have performed: Other studies have explored microvascular dysfunction, but this specific approach focusing on gender differences in Cardiac Syndrome X is relatively novel.

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

Where this trial is running

Los Angeles, California

• Cedars-Sinai Women's Heart Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: C.Noel Bairey-Merz, MD — Cedars-Sinai Medical Center
• Study coordinator: Barbra Streisand Women's Heart Center

Conditions Heart Disease; microvascular dysfunction; Microvascular