Clinical trial NCT01005485: Molecular and Morphologic Characterization of Circulating Endothelial Cells
Official title: Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myocardial Infarction
Keywords: Myocardial Infarction (MI)
Circulating Endothelial Cells (CEC)
Control Group A: (Vascular Surgery)
Control Group B: (Healthy controls)
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.

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)

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scrippshealth
state: California
Study officials:
affiliation: Scripps Translational Science Institute
name: Eric Topol, M.D.
role: PRINCIPAL_INVESTIGATOR
References: