Molecular and Morphologic Characterization of Circulating Endothelial Cells (CEC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01005485|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2009
Last Update Posted : April 4, 2019
|Condition or disease|
|Acute Myocardial Infarction|
|Study Type :||Observational|
|Actual Enrollment :||664 participants|
|Official Title:||Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||December 2020|
Patients undergoing open vascular surgery on arterial structures to better define optimal laboratory and collection techniques for isolation of CECs.
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.
- 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 ]
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.
- x 8.5 ml PAX gene (blue top) tube
- x 10 ml EDTA purple top tubes
Follow-up visits: (healthy controls only)
- x 5 ml red top (discard)
- x 10 ml EDTA purple top tube
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005485
|United States, California|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Eric Topol, M.D.||Scripps Translational Science Institute|