NCT03392415进行中（未招募）不适用
The NOrdic-Baltic Randomized Registry Study for Long-term Clinical Evaluation of Adjunction of PCI to Optimal Medical Therapy in Chronic Total Coronary Occlusion
Leif Thuesen1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥1 CTO lesion amenable to PCI.
- •Stable and stabilized coronary artery disease
- •Symptoms (angina pectoris or shortness of breath) and/or signs of reversible perfusion defect by SPECT, PET or MR and/or angiographic/echocardiographic indication of reversible ischemia.
- •CTO lesion in a major coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm).
排除标准
- •Expected survival <1 year.
- •Renal failure on dialysis.
- •Stable non-CTO lesions treated within one month.
- •Declined informed consent.
- •Regarding CMR: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants
研究组 & 干预措施
Initial conservative treatment
Active Comparator
Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions
干预措施: CTO PCI (Procedure)
initial interventional treatment
Experimental
CTO PCI attempt as initial strategy with medical optimization simultaneously
干预措施: CTO PCI (Procedure)
结局指标
主要结局
All-cause mortality
时间窗: a minimal follow-up of 6 months
All-cause mortality after inclusion of 2000 patients
Quality of life assessment
时间窗: 6 months.
Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)
次要结局
- MR perfusion(6 months)
- Echocardiography(6 months)
研究者
Leif Thuesen
Senior consultant
Aalborg University Hospital
研究点 (1)
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