Cardiac Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The number of patients in which the study intervention is successfully completed
研究概览
简要总结
Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label, non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. This study will interrogate epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. Patients will be evaluated for markers of cardiac function and left ventricular remodelling using cardiac magnetic resonance imaging (MRI). Adverse events will be monitored to ensure safety.
详细描述
RATIONALE: Following ischemic injury the extracellular matrix (ECM) of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence suggests that the epicardial application of a healthy biologic ECM may reverse the adverse ECM remodeling that takes place following ischemic injury preventing LV dilatation and subsequent heart failure. The investigators have demonstrated that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. The investigators believe that epicardial infarct repair may not only restrain the infarcted myocardium to prevent infarct expansion and LV dilatation, but owing to it's biologic nature, help to provide a healthy ECM environment restoring ECM homeostasis and architecture. The investigators therefore propose clinical investigation epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. This is a patient population commonly referred for CABG surgery. While complete surgical revascularization can prevent further ischemic insult and salvage stunned or hibernating myocardium, it does not restore function to the infarcted myocardium resulting from the acute ischemic injury. The investigator's previous studies suggest that epicardial infarct repair as an adjunct to CABG surgery in this patient population may help improve myocardial function in this previously untreatable territory.
STUDY DESIGN: This is an open-label, non-randomized, feasibility pilot study
PRIMARY OBJECTIVE:
• To evaluate the feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI).
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by ST changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
- •The patient is scheduled to undergo coronary artery bypass surgery within 6 weeks of the acute event.
- •The patient does not possess any contraindication for CMR.
- •The patient is greater then 35-years of age, English speaking, and capable of giving informed consent.
- •The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
排除标准
- •The patient is over the age of 75 years.
- •The patient has previous MI (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other LV territory.
- •The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
- •The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
- •The patient has undergone previous cardiac surgery.
- •The patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion.
- •The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery.
- •The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
- •The patient has a history of malignancy within the past year (other than squamous or basal cell carcinoma, which has been treated without evidence of recurrence).
- •The patient has a recent history of drug or alcohol abuse.
- •The patient has within 30-days of enrollment or is at anytime during this study participating in any other drug or device study.
- •The patient has a known allergy to the CorMatrix-ECM material or any component of the material.
- •Absence of non-viable myocardium within the LV on CMR.
研究组 & 干预措施
Treatment
Epicardial Infarct Repair with CorMatrix-ECM in addition to coronary artery bypass grafting
干预措施: Epicardial Infarct Repair with CorMatrix-ECM (Device)
Treatment
Epicardial Infarct Repair with CorMatrix-ECM in addition to coronary artery bypass grafting
干预措施: Coronary Artery Bypass Grafting Surgery (Procedure)
结局指标
主要结局
The number of patients in which the study intervention is successfully completed
时间窗: 6 weeks
Feasibility will be accessed through qualitative evaluation by the performing surgeon. Successful application of CorMatrix-ECM to the infarcted myocardium at the time of coronary artery bypass grafting surgery will be deemed as successful completion of the study intervention.
次要结局
- The number of patients in which regional myocardial function and tissue characteristics are successfully measured by CMR(6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(6 months)
- The number of patients in which the target myocardium can be successfully identified at the time of surgery(6 weeks)
研究者
Dr. Paul Fedak
Professor and Cardiac Surgeon
University of Calgary