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临床试验/NCT00975234
NCT00975234终止2 期

Phase II, Randomised, Controlled Study of Treatment With Revascularisation Surgery With or Without Injection of Autologous Skeletal Myoblasts in Patients With Old Myocardial Infarction

Clinica Universidad de Navarra, Universidad de Navarra12 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
发起方
入组人数
3
试验地点
12
主要终点
The primary efficacy endpoints will be evaluate the ejection fraction and wall motion score index measured by M-mode and echocardiography 12 months after surgery.

研究概览

简要总结

The purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.

详细描述

Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. Depending on the area affected by the scar, infarction can lead to a progressive and irreversible decline in cardiac function, giving way to heart failure (HF) syndrome. The molecular basis of congestive heart failure is the absence of cardiac stem cells capable of regenerating cardiac muscle. In the skeletal muscle, there are cells located beneath the basal membrane with are capable of regenerating muscle fibres; they are known as myoblasts. There are several studies with autologous myoblasts, either by direct administration during surgery or percutaneously, which could distinguish between the effect of revascularisation surgery and that of the myoblast injection. The objective of this study is compare improvement in global and regional cardiac function in patients with old MI obtained by aortocoronary bypass surgery with intracardiac administration of autologous skeletal myoblasts versus standard aortocoronary bypass surgery treatment.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery.
  • History of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years.
  • Ejection fraction from 25% to 45%.
  • Evidence of no regional viability by dobutamine echocardiography.
  • Aged from 30-80 years old.
  • Negative serology to HIV, HBV and HCV.
  • Patients without organ dysfunction.
  • Negative pregnancy test (women of childbearing age).
  • Informed consent granted.

排除标准

  • History of myocardial infarction in the 4 weeks prior to the inclusion in the study.
  • Prior history of tachycardia or ventricular fibrillation (except in patients with DAI device).
  • History of cancer (except basocellular carcinoma) or prior treatment with chemotherapy.
  • The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
  • Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
  • Pregnant or beast feeding women.

结局指标

主要结局

The primary efficacy endpoints will be evaluate the ejection fraction and wall motion score index measured by M-mode and echocardiography 12 months after surgery.

时间窗: 12 months after surgery

次要结局

  • Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.(12 month after surgery)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (12)

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