Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 27
- 主要终点
- Changes in necrotic mass ratio (%) by gadolinium retention.
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac function in patients with a chronic myocardial infarction. Preclinical studies in the porcine model of myocardial infarction have shown that the AGTP reduces infarct area and improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age, capable of giving informed consent.
- •Q wave in the ECG
- •Myocardial infarct >=50% transmularity by NMR non revascularizable (for transmurality or bad vessel).
- •Candidate to bypass for other myocardial areas
排除标准
- •Severe non cardiac co-morbidity with a reduction of life expectancy of less than 1 year
- •Severe valvular disease candidate for surgical restoration
- •Candidate to ventricular remodeling
- •Contraindication for NMR
- •Severe renal or hepatic failure
- •Abnoraml laboratory tests (no explanation at inclusion)
- •Previous cardiac intervention
- •Pregnant or breast feeding women
研究组 & 干预措施
AGTP-treatment
Patients in which the non-revascularizable area will be covered by the adipose graft and the revascularizable area will be treated with the normal procedure.
干预措施: AGTP-treatment (Procedure)
Control
Patients in with the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
干预措施: Control (Other)
结局指标
主要结局
Changes in necrotic mass ratio (%) by gadolinium retention.
时间窗: 0-3-12 months
necrotic mass ratio (%)
次要结局
- Changes in functional parameters by Nuclear Magnetic Resonance: ventricular volumes(0-3-12 months)
- Improvement in regional contractibility by NMR(0-3-12 months)
- Levels of natriuretic peptides(0-1 week-3-12 months)
- All-cause death or re-admission(12 months)
- Changes in functional parameters by Nuclear Magnetic Resonance: ventricular ejection fraction(0-3-12 months)
- Arrhythmia by 24-h Holter(0--3-12 months)
- Changes in functional parameters by NMR: Cardiac output(0-3-12 months)
- Cardiovascular death or re-admission(12 months)
研究者
Antoni Bayés Genís
Antoni Bayes-Genis, Chief of the Cardiology Service
Germans Trias i Pujol Hospital