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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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):
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Topol, M.D. | Scripps Translational Science Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scrippshealth | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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:
Follow-up visits: (healthy controls only)
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |