A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Continued Improvement in subject's symptoms
研究概览
简要总结
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
详细描述
A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.
Subjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •Be 18 years of age and older
- •Provide written informed consent
- •Have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at ISCI (In cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial).
排除标准
- •Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT.
- •Have a history of drug or alcohol abuse within the past 24 months
结局指标
主要结局
Continued Improvement in subject's symptoms
时间窗: at 3, 5, 7, 9, and 13 Years
Demonstrate change of subject's symptoms by assessing cardiac events over an extended period of time following participation in an ISCI cardiac trial where the subject received Investigational product.
次要结局
- Change in Cardiac Function via Cardiac CT(at 3, 5, 7, 9, and 13 Years)
- Evaluate change in Quality of Life via the Minnesota Living with Heart Failure(at 3, 5, 7, 9, and 13 Years)
- Change in Cardiac Function via Cardiac MRI(at 3, 5, 7, 9, and 13 Years)
- Evaluate Functional Capacity via the NYHA Class(at 3, 5, 7, 9, and 13 Years)
- Evaluate Functional Capacity via the Six Minute Walk Test(at 3, 5, 7, 9, and 13 Years)
- Evaluate change in Symptoms via cardiac events(at 3, 5, 7, 9, and 13 Years)
研究者
Joshua M Hare
Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute
University of Miami