Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 664
- 试验地点
- 1
- 主要终点
- The primary endpoint is complete molecular profiling of CEC's in up to 250 patients with a diagnosis of acute myocardial infarction (MI) and up to 25 healthy controls.
研究概览
简要总结
The primary hypothesis of this study is that circulating endothelial cells (CECs) harbor key genetic and structural characteristics predisposing individuals to acute atherosclerotic plaque rupture and heart attack.
详细描述
Endothelial injury and inflammation are pivotal underlying processes that put patients at risk for catastrophic vascular events including acute myocardial infarction (heart attack) and stroke. We seek to accelerate scientific discovery through clinically meaningful, innovative translational research, and are collaborating in a trans-disciplinary effort to define the DNA sequence of CECs and that of germ line DNA, along with RNA sequencing, mRNA expression profiling, and ultrastructural characterization of CECs in order to better understand the mechanisms leading to acute arterial plaque rupture and embolization of arterial endothelial cells in patients with acute myocardial infarction. This will enable us to create a molecular fingerprint that could identify and preempt individuals from suffering from such debilitating vascular conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 80 years old.
- •Must be reliable, cooperative and willing to comply with all protocol-specified procedures if consented.
- •Able to understand and grant informed consent
- •Subjects must meet one of the following (a-c):
- •Healthy control subjects not meeting any exclusion criteria for controls below
- •Patients scheduled for an open vascular procedure of an arterial structure
- •Patients with acute MI defined as:
- •i. Clinical history and symptoms consistent with acute MI AND ii Elevated cardiac markers (CKMB, Troponin I or T) consistent with MI (abnormals are according to enrolling institution's lab standards) AND iii. Able to complete study enrollment (consent & blood draw) within 48 hours of presentation to the study site.
排除标准
- •General Exclusion Criteria:
- •Has a significant medical condition that in the investigator's opinion may interfere with the patient's optimal participation in the study.
- •Exclusion for Healthy Controls:
- •Age greater than 35
- •Previous history of coronary artery disease or MI
- •Peripheral arterial disease
- •Hypertension (>140/90 or on blood pressure medication)
- •Sickle cell disease
- •Acute or Chronic kidney disease
- •Acute or Chronic vascular conditions, not otherwise specified
- •Active or history of inflammation of connective tissue and vascular structures (i.e. vasculitis, rheumatoid arthritis)
结局指标
主要结局
The primary endpoint is complete molecular profiling of CEC's in up to 250 patients with a diagnosis of acute myocardial infarction (MI) and up to 25 healthy controls.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Eric Topol, MD
Director, Scripps Translational Science Institute
Scripps Translational Science Institute