Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).
研究概览
简要总结
Female patients presenting with persistent chest pain despite no obstructive coronary artery disease have impaired prognosis. Stress tests are often positive or inconclusive. As much as 20% of women with chest pain and minimal angiographic CAD have evidence of myocardial ischemia, suggesting impaired coronary microcirculation. The index of microvascular resistance (IMR) is a method for indirectly investigating microvascular function in the cardiac catheterization laboratory.
66 female patients, age 30-70 years, with chest pain and "normal" or near normal coronary angiograms will be included. After coronary physiologic evaluation, patients will be randomized in a double blind study to rosuvastatin 20 mg/day or matching placebo tablets for altogether 6 months.
The investigators hypothesize that:
- A substantial number of women with chest pain and normal or minimal pathology on angiograms have microvascular dysfunction defined by a raised IMR.
- Statins, based on its pleiotropic action will improve endothelial function and thereby IMR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Age 30 - 70 years
- •Chest pain suggestive of symptomatic coronary artery disease
- •A coronary angiogram with no or minimal coronary artery disease
- •Fractional flow reserve value over 0,80
排除标准
- •Male gender
- •Age under 30 years or over 70
- •Coronary artery stenosis ≥ 33 % in any epicardial vessel
- •Fractional flow reserve value ≤ 0,80
- •Pregnant or nursing women
- •Women of childbearing potential not using contraception
- •Short life expectancy
- •Uncontrolled endocrinological disease
- •Arterial hypertension
- •Structural heart disease
- •Significant mental disorder, including dementia
- •Inability to comply with the protocol -
研究组 & 干预措施
Angina. IMR. Placebo.
干预措施: Placebo. (Drug)
Angina. IMR. Statin.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Temporal changes in microvascular perfusion indices (Index of Microvascular Function (IMR) and Coronary Flow Reserve (CFR)).
时间窗: 6 months
During a left heart catheterization IMR and CFR are measured at baseline and at 6 months. Patients are randomized to rosuvastatin vs placebo. The objectives are to determine whether women with chest pain with no or minimal angiographic coronary artery disease, have a raised index of microvascular resistance and to determine whether high-dose statin treatment will modify microvascular perfusion indices in these patients.
次要结局
- Angina pectoris classification (CCS).(6 months)
研究者
Ole Geir Solberg
Consultant, MD
Oslo University Hospital