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临床试验/NCT04828681
NCT04828681已完成不适用

Functional Coronary Angiography-Derived Index of Microcirculatory Resistance and Microvascular Obstruction in Cardiac Magnetic Resonance Imaging After ST-segment Elevation Myocardial Infarction

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 324 人开始时间: 2007年12月24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
324
试验地点
2
主要终点
Proportion of microvascular obstruction in CMR

研究概览

简要总结

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of ST-segment elevation myocardial infarction (STEMI) patients. Microvascular obstruction (MVO) in cardiac magnetic resonance (CMR) is significant prognostic indicator in STEMI patients after primary percutaneous coronary intervention (PCI). Although current gold-standard method to assess microvascular damage or dysfunction in STEMI patients is CMR and assessment of MVO, previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the presence of MVO in CMR and the risk of cardiac death or heart failure admission. Nevertheless, the need for pressure-temperature sensor wire and hyperemic agents significantly limits adoption of IMR in daily practice.

Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or thermodilution method. In this regard, the current study will evaluate the feasibility of functional angiography-derived IMR (angio-IMR) in the evaluation of MVO after successful primary PCI for STEMI.

详细描述

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of ST-segment elevation myocardial infarction (STEMI) patients. Microvascular obstruction (MVO) in cardiac magnetic resonance (CMR) is significant prognostic indicator in STEMI patients after primary percutaneous coronary intervention (PCI). Although current gold-standard method to assess microvascular damage or dysfunction in STEMI patients is CMR and assessment of MVO, previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the presence of MVO in CMR and the risk of cardiac death or heart failure admission. Nevertheless, the need for pressure-temperature sensor wire and hyperemic agents significantly limits adoption of IMR in daily practice.

Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or thermodilution method. In this regard, the current study will evaluate the feasibility of functional angiography-derived IMR (angio-IMR) in the evaluation of MVO after successful primary PCI for STEMI.

The study population will be derived from the prospective institutional AMI registry of Samsung Medical Center between December 2007 and July 2014. Main results from this registry were published elsewhere (PLoS One. 2017 Jan 12;12(1):e0170115 and Sci Rep. 2019 Jul 4;9(1):9646). In this registry, 515 consecutive patients who presented with acute myocardial infarction and underwent CMR were prospectively enrolled. AMI was defined as evidence of myocardial injury (defined as elevation of cardiac troponin values, with at least one value above the 99th percentile upper reference limit) with necrosis in a clinical setting, consistent with myocardial ischemia. Among the total patients, STEMI patients (n = 332), whose electrocardiogram showed ST-segment elevation more than 1 mm in two or more contiguous leads or a presumably new-onset left bundle branch block, will be analyzed for the current study. For the study purpose, patients with failed primary PCI (n=1), treated by medical treatment alone without PCI (n=4), and no available coronary angiographic images (n=3) will be excluded. Among the remaining 324 patients, functional coronary angiography core laboratory (Shanghai Institute of Cardiovascular Diseases, Shanghai, China) evaluated the quality of angiographic images and additionally exclude patients with insufficient image quality for angio-IMR calculation (n=37). All patients also underwent baseline and 1-year follow-up echocardiography. The Institutional Review Board of Samsung Medical Center approved this study, and all patients provided written informed consent.

The association of Angio-IMR with CMR-derived quantitative parameters (extent of MVO, infarct size, area at risk) and qualitative parameter (presence of MVO) will be analyzed. The discrimination ability of angio-IMR to predict the presence of MVO in CMR will be compared with conventional angiographic measures of culprit vessel reperfusion (TIMI flow grade, myocardial blush grade).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • STEMI patients
  • Successful primary PCI in the culprit vessel
  • Underwent cardiac MR during index hospitalization
  • Suitable coronary angiographic images for angio-IMR analysis

排除标准

  • patients with failed primary PCI
  • treated by medical treatment alone without PCI
  • no available coronary angiographic images
  • insufficient image quality for angio-IMR calculation

结局指标

主要结局

Proportion of microvascular obstruction in CMR

时间窗: At the time of index hospitalization

Proportion of microvascular obstruction in CMR

次要结局

  • Correlation of angio-IMR with the myocardial salvage index in CMR(At the time of index hospitalization)
  • Left ventricular ejection fraction(At the time of index hospitalization and 1 year follow-up)
  • Regional wall motion score index(At the time of index hospitalization and 1 year follow-up)
  • Correlation of angio-IMR with the extent of microvascular obstruction in CMR(At the time of index hospitalization)
  • Correlation of angio-IMR with the area at risk in CMR(At the time of index hospitalization)
  • Discrimination ability of angio-IMR to predict the occurrence of microvascular obstruction in CMR(At the time of index hospitalization)
  • Correlation of angio-IMR with the infarct size in CMR(At the time of index hospitalization)

研究者

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

Joo Myung Lee

Assistant Professor

Samsung Medical Center

研究点 (2)

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