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Molecular and Morphologic Characterization of Circulating Endothelial Cells (CEC)

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ClinicalTrials.gov Identifier: NCT01005485
Recruitment Status : Active, not recruiting
First Posted : November 1, 2009
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute

Tracking Information
First Submitted Date October 29, 2009
First Posted Date November 1, 2009
Last Update Posted Date March 17, 2021
Study Start Date January 2010
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular and Morphologic Characterization of Circulating Endothelial Cells
Official Title Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen 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
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.
Condition Acute Myocardial Infarction
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 2, 2017)
664
Original Estimated Enrollment
 (submitted: October 30, 2009)
325
Estimated Study Completion Date December 2025
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
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):

    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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01005485
Other Study ID Numbers IRB#09-5287
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eric Topol, MD, Scripps Translational Science Institute
Study Sponsor Scripps Translational Science Institute
Collaborators Not Provided
Investigators
Principal Investigator: Eric Topol, M.D. Scripps Translational Science Institute
PRS Account Scripps Translational Science Institute
Verification Date March 2021