NCT01473433已完成1 期
Randomized Trial to Evaluate the Safety and Efficacy of a New Surgical Approach to Cardiac Regeneration: Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).
研究概览
简要总结
The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic myocardial infarct. Preclinical studies in the porcine model of myocardial infarction have shown that AdiFLAP reduces infarct area.
详细描述
This novel intervention consists of the pericardial isolation of adipose tissue maintaining its vascularization to create an adipose flap (adiFLAP) and its transposition fully covering infarcted myocardium.
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
- Single (Participant)
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
- •Established transmural myocardial infarction non candidate to revascularization (>3 months-old)
- •Candidate to coronary by-pass for other territories different from the previous transmural infarct.
- •> 18 years of age, male or female, capable of giving an informed consent.
排除标准
- •Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- •Severe valvular disease candidate for surgical restoration.
- •Candidate to ventricular remodeling.
- •Contraindication for NMR (creatinin clearance <30 ml/min/1.73m2, metallic implants, claustrophobia).
- •Severe renal or hepatic failure.
- •Abnormal laboratory tests (no explanation at the time of inclusion).
- •Previous cardiac intervention.
- •High surgical risk (Euroscore 2).
- •Pregnant or breast feeding women.
结局指标
主要结局
Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).
时间窗: 12 months
次要结局
- Improvement of cardiac function as changes in clinical variables, cardiac magnetic resonance imaging and echocardiography, and biochemical variables (NTproBNP and high sensitivity troponin T).(12 months)
研究者
Antoni Bayés Genís
Chief of the Cardiology Service
Germans Trias i Pujol Hospital
研究点 (2)
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