Status:
ACTIVE_NOT_RECRUITING
Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Florida
Conditions:
Cardiovascular Disease
Eligibility:
FEMALE
18-85 years
Brief Summary
This research study is designed to investigate the approaches to noninvasive detection and assessment of coronary vascular dysfunction in women by comparing the testing results from the invasive stand...
Detailed Description
See Brief Summary above.
Eligibility Criteria
Inclusion
- Symptomatic angina or anginal equivalent;
- Aged 18 years or older;
- No obstructive CAD at coronary angiography (performed within the previous 24 months).
- Competent to give informed consent.
Exclusion
- 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,
- Acute MI;
- 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 CMRI (e.g., AICD, pacemaker, untreatable claustrophobia or known angio-edema).
- Contraindications to adenosine or Regadenoson (Lexiscan)
- Women 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-obstructing stenosis will be excluded from the overall study.
- Participation in a research study that conflicts with the current WISE study.
- Women with coronary stenosis ≥ 50% in any epicardial coronary artery, assessed visually at the time of angiography, will not be included in the CRT subgroup.
Key Trial Info
Start Date :
September 17 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2051
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT00832702
Start Date
September 17 2008
End Date
August 31 2051
Last Update
September 19 2025
Active Locations (2)
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1
Cedars-Sinai Barbra Streisand Women's Heart Center
Los Angeles, California, United States, 90048
2
University of Florida
Gainesville, Florida, United States, 32610-0277