Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Baseline Frequency of adverse events and serious adverse events
研究概览
简要总结
The goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. The main questions it aims to answer are:
- Is this study feasible in terms of recruiting enough people to participate in this study?
- How often do heart complications happen in people who are at high risk of heart complications and are having a surgery that is not on the heart?
Participants will have their usual care and will also be asked to:
- Have extra bloodwork done
- Complete some surveys
- Have two echocardiograms (ultrasounds of the heart)
- Continue to follow-up with the research team for one year after their surgery
Researchers will compare how often heart complications occur in this high risk population to a future study where participants will receive stem cells before their surgery.
详细描述
This observational trial protocol is to collect baseline health data from participants undergoing intermediate to high-risk surgery and at high risk of developing perioperative myocardial ischemic complications for an upcoming Phase 1 trial that determines the feasibility of intravenous delivery of umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in the same patient population. Participants enrolled in this protocol, however, will not receive cell product; they will receive standard of care and serve as a lead in control group for the interventional study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A participant must meet all 5 inclusion criteria to be eligible:
- •Referred for elective intermediate to high risk noncardiac surgery as defined by the American Heart Association guidelines (e.g., intrathoracic, open intraabdominal, or open vascular surgery)
- •45 years of age or older
- •Revised cardiac risk index ≥ 2
- •NT-proBNP level of ≥ 200 pg/mL
- •Able to provide informed consent
排除标准
- •Experience an acute coronary syndrome, myocardial infarction, heart failure, or stroke within preceding 3 months
- •Coronary revascularization anticipated during the study period
- •Severe mitral/aortic valve stenosis
- •Evidence of clinically significant arrhythmia in last three months.
- •Major surgical procedure in previous 3 months
- •History of malignancy requiring surgery, chemotherapy, immunotherapy, or radiation within previous 5 years
- •Ongoing malignancy requiring surgical resection
- •Women who are pregnant, breastfeeding, or of childbearing potential who are unable to use a medically acceptable form of contraception throughout the study
- •Received any experimental cell therapy previously
- •Unable to provide written informed consent
结局指标
主要结局
Baseline Frequency of adverse events and serious adverse events
时间窗: 1 year
To determine the baseline frequency of adverse events and serious adverse events in this high risk population
Feasibility of Participant Recruitment
时间窗: 1 year
Our primary outcome is the feasibility of participant recruitment. This will be determined by measurements of recruitment efficiency: 1) proportion of potentially eligible participants that are successfully screened; 2) proportion of participants successfully screened who do not enroll (reason for failure to enroll will be recorded).
次要结局
- Quality of life of participants(1 year)