Molecular and Morphologic Characterization of Circulating Endothelial Cells (CEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Scripps Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01005485
First received: October 29, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells

Resource links provided by NLM:


Further study details as provided by Scripps Translational Science Institute:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 325
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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):

    1. Healthy control subjects not meeting any exclusion criteria for controls below
    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.

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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005485

Contacts
Contact: Sharon Haaser, BSN, RN 858-554-5758 haaser.sharon@scrippshealth.org
Contact: Sarah Topol, BSN, RN 858-554-5747 topol.sarah@scrippshealth.org

Locations
United States, California
Scrippshealth Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Eric Topol, M.D.         
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
Principal Investigator: Eric Topol, M.D. Scripps Translational Science Institute
  More Information

No publications provided

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01005485     History of Changes
Other Study ID Numbers: IRB#09-5287
Study First Received: October 29, 2009
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Translational Science Institute:
Myocardial Infarction (MI)
Circulating Endothelial Cells (CEC)
Control Group A: (Vascular Surgery)
Control Group B: (Healthy controls)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014