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临床试验/NCT01162902
NCT01162902Unknown4 期

Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
150
试验地点
1
主要终点
Wall to lumen ratio of fundus vessel

研究概览

简要总结

Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).

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
Single (Participant)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
  • Unstable Angina/NSTEMI patients who completed PCI for main lesions
  • Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs

排除标准

  • STEMI patients within one month
  • Variant Angina
  • Liver function abnormality or renal failure
  • History of Hypersensitivity to testing drugs
  • Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
  • Woman possible to be pregnant
  • Uncontrolled diabetes
  • Expected life span < one year

研究组 & 干预措施

Candesartan treated group

Active Comparator

Candesartan 32mg treated group

干预措施: Candesartan treated group (Drug)

Diltiazem treated group

Experimental

Diltiazem 180mg treated group

干预措施: Diltiazem treated group (Drug)

Bisoprolol treated group

Active Comparator

Bisoprolol 5mg treated group

干预措施: Bisoprolol treated group (Drug)

结局指标

主要结局

Wall to lumen ratio of fundus vessel

时间窗: baseline, 9 months

Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up

次要结局

  • Serum markers of inflammation(baseline, 9 months)
  • lipid parameter(baseline, 9 months)
  • Change of nitrate need(baseline, 1 months, and 3 months)

研究者

申办方类型
Other

研究点 (1)

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