Molecular and Morphologic Characterization of Circulating Endothelial Cells

NCT ID: NCT01005485

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 664 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Group A

Patients undergoing open vascular surgery on arterial structures to better define optimal laboratory and collection techniques for isolation of CECs.

No interventions assigned to this group

Group B

Healthy controls will be recruited from the general medical population, community.

No interventions assigned to this group

Acute Myocardial Infarction

Patients with acute myocardial infarction with or without ST segment deviation.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age 18 - 80 years old.

2. Must be reliable, cooperative and willing to comply with all protocol-specified procedures if consented.

3. Able to understand and grant informed consent

4. Subjects must meet one of the following (a-c):

Exclusion Criteria

2. Patients scheduled for an open vascular procedure of an arterial structure

3. 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.

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:

1. Age greater than 35

2. Previous history of coronary artery disease or MI

3. Diabetes

4. Peripheral arterial disease

5. Hypertension (>140/90 or on blood pressure medication)

6. Sickle cell disease

7. Acute or Chronic kidney disease

8. Acute or Chronic vascular conditions, not otherwise specified

9. Active or history of inflammation of connective tissue and vascular structures (i.e. vasculitis, rheumatoid arthritis)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scripps Translational Science Institute

OTHER

Sponsor Role: lead

Responsible Party

Eric Topol, MD

Director, Scripps Translational Science Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Topol, M.D.

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Science Institute

Locations

Scrippshealth

La Jolla, California, United States

Countries

United States

Other Identifiers

IRB#09-5287

Identifier Type: -

Identifier Source: org_study_id