Status:
COMPLETED
QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Ischemic Heart Disease
Eligibility:
FEMALE
21-75 years
Phase:
PHASE4
Brief Summary
INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin converting enzyme) inhibition (quinapril) in improving coronary microvascular function. PATIENT POPULATION Wo...
Detailed Description
A prospective, randomized, placebo-controlled, comparative trial evaluating the effects of ACE inhibition on microvascular function in women with coronary flow reserve limitations and chest discomfort...
Eligibility Criteria
Inclusion
- Non pregnant women with chest discomfort 21 to 75 years of age from diverse racial/ethnic groups.
- Suspected ischemic heart disease (IHD) but no severe coronary stenosis (\> 50% diameter reduction) on coronary angiography used to qualify for WISE.
- Coronary flow reserve limitation (\<3.0 velocity).
Exclusion
- Women who are breast-feeding or who are pregnant. Women of childbearing potential may be enrolled but must agree not to become pregnant during the course of the study and must practice a method of birth control considered reliable by the investigator. If established on hormonal contraceptives for more than 3 months, patients will be allowed to participate providing this therapy remains constant throughout the study. If a patient becomes pregnant or begins breast-feeding during the study, she must be withdrawn immediately.
- Acute ischemic syndrome defined as acute myocardial infarction (MI) (by enzyme or electrocardiogram (ECG) criteria) or unstable angina within 1 month of entry.
- Uncontrolled moderate hypertension: Sitting blood pressure \>160/95mmHg with measurements recorded on at least 2 occasions (for blood pressure control, patients must first be stabilized, preferably with a diuretic, and kept on that dosing regimen throughout participation in the study).
- Severe heart failure defined as New York Heart Association (NYHA) Class III or IV on treatment.
- Coronary revascularization by either coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) or Stent Placement.
- Conditions likely to influence outcomes independent of IHD: Severe lung, renal (creatinine \>3.0) or hepatic disease, surgically uncorrected significant congenital or valvular heart disease and other disease likely to be fatal or require frequent hospitalization within the next six months.
- Adherence or retention reasons: Recent alcoholism or drug abuse, psychiatric illness including severe depression, dementia, active participation in any other research trial other than WISE, unwilling to complete follow-up evaluation including repeat testing.
- Hypersensitivity to any medications to be used in the study (e.g. angioedema to ACE-I).
- Documented obstructive hypertrophic cardiomyopathy.
- Aortic stenosis (valve area \<1.5cm).
- LV dysfunction (ejection fraction \<=35%).
- History of cocaine or amphetamine abuse.
- ACE-I or angiotension 1 (AT-1) receptor blocker use within 30 days or need for continued ACEI/AT-1RB use.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00150826
Start Date
May 1 2000
End Date
December 1 2004
Last Update
April 13 2012
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610