跳至主要内容
临床试验/NCT04058782
NCT04058782进行中(未招募)不适用

Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年2月17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
MACE: Major adverse cardiovascular events

研究概览

简要总结

Risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. The RIGID-MI study proposes to deeply evaluate at 1 month after MI: peripheral vascular disease, vascular stiffness, ventriculo-arterial coupling and other usual risk factors. The main objective is to identify clinical, biological and imaging parameters associated with poor prognosis, especially evolution toward diastolic heart failure, recurrence of MI, and bleeding.

研究设计

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

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

  • •Signed informed consent
  • •Affiliated to national health insurance (French social security number)
  • •Presenting with MI within 48 hours of symptom onset

排除标准

  • •Patient under curatorship
  • •Type 2 MI
  • •Presenting with MI after 48 hours of symptom onset
  • •Pregnancy or lactating
  • •Refuse to participate
  • •No national health insurance (No French social security number)

研究组 & 干预措施

Patients with myocardial

干预措施: Imaging evaluation for vascular assessment (Other)

结局指标

主要结局

MACE: Major adverse cardiovascular events

时间窗: at 5 years

A composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, acute limb ischemia, coronary revascularization, hospitalization for heart failure

次要结局

  • All-cause death(at 5 years)
  • Cardiovascular death(at 5 years)
  • Myocardial infarction(at 5 years)
  • Systemic embolism(at 5 years)
  • Bleeding as assessed by GUSTO Bleeding Criteria(at 5 years)
  • Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteria(at 5 years)
  • Ischemic stroke(at 5 years)
  • Bleeding as assessed by ISTH definitions(at 5 years)
  • Acute limb ischemia(at 5 years)
  • Coronary revascularization(at 5 years)
  • Hospitalization for heart failure(at 5 years)
  • Bleeding as assessed by Bleeding Academic Research Consortium (BARC)(at 5 years)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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