Molecular and Morphologic Characterization of Circulating Endothelial Cells

NCT01005485 | Active Not Recruiting

• 1 other identifier: IRB#09-5287
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

Myocardial Infarction (MI); Circulating Endothelial Cells (CEC); Control Group A: (Vascular Surgery); Control Group B: (Healthy controls)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the general in-patient and out-patient populations for myocardial infarction and/or vascular surgery. Healthy controls will be recruited from the general medical population and community.

You may qualify if:

• 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):

You may not qualify if:

• 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.
• \. Has a significant medical condition that in the investigator's opinion may interfere with the patient's optimal participation in the study.
• 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)

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scrippshealth

La Jolla, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for each patient will be collected from arterial access established as part of standard of care or via venipuncture. Blood must be collected in the order listed below. By drawing the PAX gene tube first, the likelihood of contamination of the sample with vessel wall endothelial cells is decreased. Enrollment: 1. x 8.5 ml PAX gene (blue top) tube 2. x 10 ml EDTA purple top tubes Follow-up visits: (healthy controls only) 1. x 5 ml red top (discard) 2. x 10 ml EDTA purple top tube

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Eric Topol, M.D.

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scripps Translational Science Institute

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 2, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

US (1)