跳至主要内容
临床试验/NCT05194865
NCT05194865Unknown不适用

Comparison Between Coronary Revascularization Based on CMR Viability Study Vs Direct Revascularization in Patients With Ischemic Cardiomyopathy

Assiut University0 个研究点目标入组 15 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
主要终点
Detection of death, myocardial infarction , arrhythmia and hospitalization for HF

研究概览

简要总结

The study aiming to demonstrate the baseline characteristics and outcomes of patients undergoing revascularization by PCI vs those kept only on medical treatment, based on CMR viability assessment.

详细描述

Cardiac magnetic resonance (CMR) has an ever-increasing role in the assessment and management of patients with coronary artery disease (CAD). Advantages of CMR include the lack of ionizing radiation and its flexibility, high spatial resolution, and three-dimensional capabilities that enable imaging in any desired plane.

In the evaluation of patients with ischemic cardiomyopathy, CMR is primarily used in the setting of chronic CAD for the evaluation of myocardial ischemia and viability.

Left ventricular systolic dysfunction, resulting from coronary artery disease is reversible with revascularization in cases of hibernation and stunned myocardium. Revascularization is dependent not only on the presence but also the extent of viability, and a viable myocardium is necessary for functional recovery.

In a CMR study, in areas with dysfunctional myocardium as detected in cine sequences, the end diastolic wall thinning >5.5 mm, the extent of subendocardial fibrosis together with response to low dose dobutamine were shown to predict functional recovery.

However, in the famous viability sub study of the STICH (Surgical Treatment for Ischemic Heart Failure) trial, there was a significant association between myocardial viability and outcome by univariate analysis, but not on multivariable analysis. Thereby, the value of CMR in this regards is still debatable.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients >18 years of age, with LVEF<40%.
  • Patients presenting for viability assessment to Assiut university Heart Hospital, starting from October 2020 till September 2021, will be retrospectively recruited.
  • Patients with a coronary angiography that is amenable for revascularization. The decision and type of revascularization will be determined by the treating physicians.

排除标准

  • Classic CMR and gadolinium-based dye contraindications including non-MRI compatible implants/foreign bodies (e.g. non-MRI compatible pacemaker, large pieces of shrapnel) and patients with eGFR<30 ml/min/1.73 m
  • Patients with non-ischemic cardiomyopathy confirmed by both CMR and coronary angiography.

结局指标

主要结局

Detection of death, myocardial infarction , arrhythmia and hospitalization for HF

时间窗: 6-12 months after revascularization or medical treatment based on CMR viability testing.

Detection of death, myocardial infarction (not related to index procedure) and hospitalization for heart failure or arrhythmia at 6-12 months after revascularization or medical treatment based on CMR viability testing.

次要结局

  • - Quality of life assessment using Kansas Qol questionnaire.(6-12 months after revascularization or medical treatment based on CMR viability testing.)
  • - Improvement of echocardiography measured LVEF at 6-12 months after revascularization.(6-12 months after revascularization or medical treatment based on CMR viability testing.)
  • - Detection of the effect of delayed revascularization after the CMR viability study on the outcome.(6-12 months after revascularization or medical treatment based on CMR viability testing.)

研究者

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

Ahmed Attiya Abdelmuty Mahmoud

Resident doctor

Assiut University

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