Heart Disease of the Small Arteries in Women and Men

Launched by CEDARS-SINAI MEDICAL CENTER · Dec 12, 2007

Keywords

ClinConnect Summary

This clinical trial is investigating a type of heart disease known as Cardiac Syndrome X, which affects more women than men. This condition causes chest pain even though the larger blood vessels of the heart appear normal. Researchers believe that small blood vessels in the heart may not be functioning properly, which can lead to missed diagnoses and delayed treatment, especially in women. The goal of the trial is to better understand this condition and find effective treatments, as current testing for these small vessel issues is not routinely done.

To participate in this study, individuals must be over 18 years old and have symptoms like chest pain that might indicate heart issues, but without significant blockages in the major coronary arteries. The trial is open to both men and women. Participants will undergo specialized tests to help identify any problems with the small blood vessels and may receive treatments that could improve their heart health. This study aims to ultimately help those who suffer from this often misunderstood condition and reduce the healthcare costs associated with misdiagnosis.

Gender

ALL

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