跳至主要内容
临床试验/NCT00781404
NCT00781404已完成3 期

Myocardial Protection During reperfusión in Patients With Acute Coronary Syndrome With ST Segment Elevation Submitted to Primary Angioplasty: Effect of Intracoronary Adenosine on Infarct Size and Ventricular Remodeling.

David Garcia-Dorado2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2008年10月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
201
试验地点
2
主要终点
Infarct size measured by MRI

研究概览

简要总结

OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP.

DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study.

PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset.

详细描述

The main mechanism responsible for the sanitary impact of ischemic heart disease is cardiomyocyte cell death associated to acute coronary syndrome with ST segment elevation (ACSST). In most of these patients, performing PTCA or thrombolysis as soon as possible does not prevent the occurrence of myocardial necrosis involving a substantial portion of the area at risk. Intracoronary adenosine (ADO) at the time of reperfusion limits infarct size in animals, and preliminary clinical studies indicate that may be also protective in patients with ACSST receiving early reperfusion therapy. OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP. DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study. PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset. PROTOCOL: Intracoronary ADO (4mg) or placebo (saline) infusion distal to the culprit lesion immediately before stent deployment, NMR between 6 and 14 days and after 6 months. END-POINTS: Major: infarct size as measured by NMR, Secondary: changes in LV volumes and EF, and major cardiac events during the follow-up.

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 (Participant, Investigator)

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 older than 18 years.
  • patients with acute coronary syndrome with ST segment elevation within six hours of the onset of symptoms.

排除标准

  • patients younger than 18 years and pregnant women.
  • patients with previous transmural infarction.
  • patients with clinical evidence of bronchospastic lung disease or prior bronchodilator therapy.
  • patients with pacemakers.
  • patients with TIMI flow higher than 1 and lower than 3.

结局指标

主要结局

Infarct size measured by MRI

时间窗: between 5 and 10 days after acute myocardial infarction

次要结局

未报告次要终点

研究者

发起方
David Garcia-Dorado
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Garcia-Dorado

MD

Hospital Universitari Vall d'Hebron Research Institute

研究点 (2)

Loading locations...

相似试验

Myocardial Protection With Adenosine During Primary... | 临床试验