Molecular and Morphologic Characterization of Circulating Endothelial Cells

Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01005485

Acronym

CEC

Enrollment

664

Registered

2009-11-02

Start date

2010-01-31

Completion date

2025-12-31

Last updated

2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Myocardial Infarction (MI), Circulating Endothelial Cells (CEC), Control Group A: (Vascular Surgery), Control Group B: (Healthy controls)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results