QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia; Chest Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin
      converting enzyme) inhibition (quinapril) in improving coronary microvascular function.

      PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE
      (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow
      reserve limitations and evidence for myocardial ischemia in the absence of significant
      coronary artery stenosis.

      STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT
      Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow
      reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific
      variables, and site by treatment effects.

      SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle
      Angina Questionnaire adjusting for baseline values, site, and site by treatment effects.

      SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and
      occurrence of adverse events.

      STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the
      study has been provided. Interim analyses are planned after 15 patients have been enrolled in
      each group.

      ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT
      EACH SITE Approximately 26
    

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. Women who are enrolled in the WISE study can be enrolled into this
      ancillary study if they meet the study criteria. Women not enrolled in the WISE study can
      also be entered into this ancillary study as long as they too meet the study criteria. After
      WISE evaluations including symptom assessment using the Seattle Angina Questionnaire (SAQ)
      and documented reduced coronary blood flow reserve (<3.0 velocity), patients will be
      randomized to double-blind placebo or quinapril (started at 40 mg/d and titrated to 80 mg/d
      by the end of the first week). After treatment on the maximum tolerated dose for 16 weeks,
      patients will be reevaluated with coronary angiogram with coronary flow reserve measurements
      and assessment of angina using the SAQ.
    

Intervention name(s): Quinapril; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Quinapril will be started at 40mg daily and titrated to 80mg daily for 16 weeks.; Placebo will be given in a capsule form once daily for 16 weeks.
Intervention MeSH terms: Quinapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: microvascular disease; women; renin angiotensin system; WISE; ischemic heart disease