A Pilot Study for Quantifying New Heart Muscle Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of labeled cardiomyocytes for each patient
研究概览
简要总结
Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration.
The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion.
- •The investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection.
- •Diagnosis of ToF/PS or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research
排除标准
- •Patients with low chance of having resection of myocardium as part of their surgical care.
结局指标
主要结局
Percentage of labeled cardiomyocytes for each patient
时间窗: 6 months
The investigators will use, multi-isotope imaging mass spectrometry (MIMS) to quantify the generation of new cardiomyocytes by examining myocardial samples that are routinely resected and discarded during cardiac surgery. Investigators will then calculate the percentage of labeled, i.e. newly generated, cardiomyocytes, for each patient. The data from the analysis of myocardial samples will be the test results. Investigators will first compare these results with technical controls.
次要结局
未报告次要终点