NCT04695522Unknown1 期
Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of complication associated with drug administration method
研究概览
简要总结
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
- •Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
排除标准
- •Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
- •Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
结局指标
主要结局
Number of complication associated with drug administration method
时间窗: 26 weeks
Feasibility of drug administration method
Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery
时间窗: 26 weeks
Efficacy (Exploratory)
Number of participants with Adverse event
时间窗: 26 weeks
Safety assessment related to adverse events and this product
次要结局
未报告次要终点
研究者
Daisuke Mori
Assistant professor
Osaka University
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery PatientsIschaemic Heart DiseaseContrast-induced NephropathyNCT03736018Queen Mary University of London688
已完成
1 期
Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass SurgeryCoronary Heart DiseaseNCT00397163University College London Hospitals200
招募中
不适用
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)RevascularizationHeart FailureNCT05532631Assistance Publique - Hôpitaux de Paris1,040
已完成
2 期
Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.Chronic Myocardial IschemiaNCT01454323Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud20
Unknown
1 期
CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic CardiomyopathyIschemic CardiomyopathyCongestive Heart FailureCoronary Artery DiseaseNCT00972114China National Center for Cardiovascular Diseases70