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临床试验/NCT04628377
NCT04628377已完成不适用

Prognostic Implication of Angiography-Derived Index of Microcirculatory Resistance in Successfully Reperfused STEMI Patients

Samsung Medical Center0 个研究点目标入组 333 人开始时间: 2003年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
333
主要终点
Cardiac death or heart failure admission

研究概览

简要总结

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

详细描述

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

The study cohorts consist with 2 separate cohort: first, diagnostic accuracy cohort, which will evaluate diagnostic accuracy of angiography-derived IMR for invasive IMR. For this, 31 patients with culprit vessel IMR measurement at the time of primary PCI will be evaluated. The patients cohort is the subgroup of previous registry (NCT02186093). Second, prognosis cohort, in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization. Those patients have follow-up data after 10 years from index procedure. This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center, whose results were previously published (JACC Cardiovascular Intervention. 2019 Apr 8;12(7):607-620.) Among 490 STEMI patients from the overall study cohorts, 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed. Primary clinical outcome will be cardiac death at 10 years from index procedure. Secondary outcome will be any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, congestive heart failure admission at 10 years from index procedure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • STEMI patients who were successfully revascularized for culprit vessel
  • analyzable angiograms at the index procedure

排除标准

  • Previous coronary artery bypass grafting
  • Coronary bypass graft as culprit vessel
  • Patients with unclear culprit vessel
  • limited image quality of coronary angiography
  • Insufficient angiographic project for TIMI frame count
  • Severe tortuosity of culprit vessel
  • No optimal projection for reconstruction

结局指标

主要结局

Cardiac death or heart failure admission

时间窗: at 10 years from index procedure

Cardiac death or heart failure admission

Diagnostic accuracy

时间窗: at the index procedure

Diagnostic accuracy of angiography-derived IMR to predict invasive IMR

次要结局

  • Any myocardial infarction(at 10 years from index procedure)
  • Stent thrombosis(at 10 years from index procedure)
  • Heart failure admission(at 10 years from index procedure)
  • Congestive heart failure admission(at 10 years from index procedure)
  • Ischemia-driven revascularization(at 10 years from index procedure)
  • Major adverse cardiac events(at 10 years from index procedure)
  • All-cause death(at 10 years from index procedure)
  • Cardiac death(at 10 years from index procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joo Myung Lee

Assistant Professore

Samsung Medical Center

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