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Molecular and Morphologic Characterization of Circulating Endothelial Cells (CEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 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: November 17, 2014
Last verified: November 2014

October 29, 2009
November 17, 2014
January 2010
March 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01005485 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Molecular and Morphologic Characterization of Circulating Endothelial Cells
Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells

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.

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.

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

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
Non-Probability Sample

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.

Acute Myocardial Infarction
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
325
December 2016
March 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
Yes
Contact: Emily Spencer, PhD 858-554-5709 spencer.emily@scrippshealth.org
Contact: Sarah Topol, BSN, RN 858-554-5747 topol.sarah@scrippshealth.org
United States
 
NCT01005485
IRB#09-5287
No
Eric Topol, MD, Scripps Translational Science Institute
Scripps Translational Science Institute
Not Provided
Principal Investigator: Eric Topol, M.D. Scripps Translational Science Institute
Scripps Translational Science Institute
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP