Molecular and Morphologic Characterization of Circulating Endothelial Cells

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: General Exclusion Criteria: 1. 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 Diabetes 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients undergoing open vascular surgery on arterial structures to better define optimal laboratory and collection techniques for isolation of CECs. | |
| Group B<br>Healthy controls will be recruited from the general medical population, community. | |
| Acute Myocardial Infarction<br>Patients with acute myocardial infarction with or without ST segment deviation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Infarction (MI), Circulating Endothelial Cells (CEC), Control Group A: (Vascular Surgery), Control Group B: (Healthy controls)