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临床试验/NCT02715518
NCT02715518已完成不适用

Comparison of Clinical Outcomes Between Fractional Flow Reserve-guided Strategy and Angiography-guided Strategy in Treatment of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 1,292 人开始时间: 2016年8月19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
1,292
试验地点
2
主要终点
Patient-oriented composite outcome

研究概览

简要总结

The aim of the study is to compare clinical outcomes following fractional flow reserve (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel disease

Prospective, open-label, randomized, multicenter trial to test the clinical outcomes following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in patients with acute AMI with multivessel disease.

详细描述

The presence of ischemia is a prerequisite for the improvement of clinical outcomes with percutaneous coronary intervention (PCI). It is well-known that the discrepancy exists between angiographic stenosis severity and the presence of myocardial ischemia. This discrepancy cannot completely overcome with even more precise invasive imaging modalities such as intravascular ultrasound or optical coherence tomography.

Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia.

However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from non-acute myocardial infarction patients.1, 3-5 Recently FAMOUS-NAMI trial evaluated 176 patients with acute non-ST elevation myocardial infarction (NSTEMI) with multivessel disease, and demonstrated feasibility of FFR measurement in acute NSTEMI patients and also presented that FFR-guided decision making for non-infarct related artery (IRA) stenosis was significantly reduced unnecessary stent implantation without any difference in major adverse cardiovascular events at 1-year as well as medical cost, compared with angiography-only guided decision making process.

Nevertheless, there have been no evidence in clinical setting of acute myocardial infarction (AMI). Since about 30-50% of patients with AMI possess multivessel disease, the ability to accurately assess the functional significance of non-IRA stenoses at the time of initial primary PCI would potentially facilitate revascularization decisions with potential for health and economic benefit. Moreover, avoiding unnecessary stent implantation for non-IRA stenoses in patients with AMI with multivessel disease would reduce the possibility of stent- or procedure related complications, and enhance long-term prognosis of patients.

Therefore, the FRAME-AMI trial will compare clinical outcomes after index primary PCI between FFR-guided strategy versus angiography only-guided strategy for management of non-IRA stenoses in AMI with multivessel disease patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Clinical event adjudication and statistical analysis will be blindly performed by independent investigators.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient-oriented composite outcome

时间窗: 24 months

a composite of death, myocardial infarction, or repeat revascularization

次要结局

  • Cardiac death(24 months)
  • All-cause mortality(24 months)
  • Any myocardial infarction without procedure-related myocardial infarction(24 months)
  • Any myocardial infarction with periprocedural myocardial infarction(24 months)
  • Non-IRA repeat revascularization(24 months)
  • Stent thrombosis(24 months)
  • Total amount of contrast use(1 week)
  • All-cause death and myocardial infarction(24-month)
  • Any revascularization(24 months)
  • Infarct-related artery (IRA) repeat revascularization(24 months)
  • Stroke(24 months)
  • Incidence of contrast-induced nephropathy(3 days)
  • Seattle Angina Questionnaires(24-month)
  • Death, spontaneous myocardial infarction, or repeat revascularization(24-month)

研究者

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

Joo-Yong Hahn

Professor

Samsung Medical Center

研究点 (2)

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