Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
研究概览
简要总结
This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells.
Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing.
Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation.
The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.
详细描述
In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:
- periodic physical examination and blood tests
- non-invasive imaging studies may include echocardiography and magnetic resonance imaging
- electrocardiogram at rest and during treadmill testing (may include spiroergometry testing)
- interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Clinical diagnosis of heart disease with signs and symptoms of heart failure due to
- •acute myocardial infarction or
- •ischemic cardiomyopathy with or without previous myocardial infarction or
- •dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease, history of myocarditis (no active myocardial infection present)
排除标准
- •none, all patients meeting the inclusion criteria will be eligible.
结局指标
主要结局
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
时间窗: 10 years
次要结局
未报告次要终点
研究者
A. M. Zeiher
Prof. Dr. Andreas M. Zeiher
Johann Wolfgang Goethe University Hospital