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临床试验/NCT06054126
NCT06054126招募中不适用

The Development of Coronary Collateralization in Type 2 Diabetic Patients With Chronic Total Occlusion

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Cardiac function evaluated by echocardiography

研究概览

简要总结

A severe coronary artery obstruction is a prerequisite for spontaneous collateral recruitment. The formation of coronary collateral circulation(CCC) is significantly impaired in type 2 diabetic patients with chronic total occlusion (CTO) compared with non-diabetic patients with CTO. This retrospective cohort enrolls consecutive T2DM patients who had at least one lesion with coronary angiographic total occlusion.

详细描述

COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion (COLLECT) study is a single center, retrospective cohort study to investigate potential factors associated with the development of coronary collateral circulation in diabetic patients. Investigators will consecutively enroll T2DM patients who had at least one lesion with coronary angiographic total occlusion. The development of coronary collateral circulation will be graded according to the Rentrop method and patients will be divided into poor CCC (grade 0 or 1) or good (grade 2 or 3) CCC groups according to their Rentrop grades. Baseline clinical and laboratory characteristics at hospital admission will be recorded to analyze potential factors associated with the development of coronary collateral circulation in T2DM patients with CTO. Later, their cardiac function will be evaluated by echocardiography at one year follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-90 years
  • Type 2 diabetes diagnosed by one of the following criteria:
  • HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents.
  • At least one lesion with angiographic total occlusion

排除标准

  • eGFR<15mL/(min·1.73m2)
  • chronic heart failure with NYHA grade ≥3
  • had a history of coronary artery bypass grafting
  • had received a percutaneous coronary intervention within the prior 3 months
  • Malignant tumor or immune system disorders
  • Pulmonary heart disease

结局指标

主要结局

Cardiac function evaluated by echocardiography

时间窗: 12 months

Assessed by echocardiography

次要结局

  • Cardiovascular events(up to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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