Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT00573027

Heart Disease of the Small Arteries in Women and Men

Led by Cedars-Sinai Medical Center · Updated on 2023-09-01

634

Participants Needed

1

Research Sites

1782 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Heart Disease of the Small Arteries in Women and Men

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 defined as angina and ischemic ECG changes without obstructive coronary artery stenosis or epicardial spasm
  • No obstructive coronary artery disease within the previous 24 months (less than 50% blockage in one or more coronary arteries on angiography)
  • Age over 18 years
  • Competent to give informed consent
Not Eligible

You will not qualify if you...

  • Obstructive coronary artery disease with 50% or more blockage in one or more epicardial coronary arteries
  • Acute coronary syndrome as defined by ACC/AHA criteria
  • Primary valvular heart disease needing valve repair or replacement
  • Cardiogenic shock or need for inotropic or intra-aortic balloon support
  • Prior or planned percutaneous coronary intervention or coronary artery bypass grafting or acute myocardial infarction within the prior 30 days
  • Non-cardiac illness with life expectancy less than 4 years
  • Unable to give informed consent
  • Chest pain due to non-ischemic causes (such as pericarditis, pneumonia, esophageal spasm)
  • Contraindications to adenosine or Regadenoson (Lexiscan)
  • Intermediate coronary stenoses between 20% and 50% leading to exclusion if flow or fractional flow reserve indicates obstruction
  • Heart failure classified as NYHA Class III or IV on treatment
  • Left ventricular dysfunction with ejection fraction less than 40%
  • Documented obstructive myocardiopathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cedars-Sinai Women's Heart Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

B

Barbra Streisand Women's Heart Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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