跳至主要内容
临床试验/NCT03010423
NCT03010423终止4 期

An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)

Merck KGaA, Darmstadt, Germany1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
8
试验地点
1
主要终点
Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12

研究概览

简要总结

The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Nicorandil

Experimental

干预措施: Nicorandil (Drug)

结局指标

主要结局

Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12

时间窗: Baseline, Week 12

Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.

次要结局

  • Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12(Baseline, Week 12)
  • Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12(Baseline, Week 12)
  • Change From Baseline in Ejection Fraction at Week 12(Baseline, Week 12)
  • Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12(Baseline, Week 12)
  • Change From Baseline in Left Ventricular Wall Thickness at Week 12(Baseline, Week 12)
  • Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12(Baseline, Week 12)
  • Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12(Baseline, Week 12)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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