CEC: Molecular and Morphologic Characterization of Circulating Endothelial Cells

Sponsor

Scripps Translational Science Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01005485

Collaborator

(none)

664

Enrollment

Location

191

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction

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.

Study Design

Study Type:

Observational

Actual Enrollment :

664 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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:

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)