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NCT Number: NCT01005485

Molecular and Morphologic Characterization of Circulating Endothelial Cells

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scrippshealth

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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):
  • Healthy control subjects not meeting any exclusion criteria for controls below
  • Patients scheduled for an open vascular procedure of an arterial structure
  • 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:

  • 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:

  • Age greater than 35
  • Previous history of coronary artery disease or MI
  • Diabetes
  • Peripheral arterial disease
  • Hypertension (>140/90 or on blood pressure medication)
  • Sickle cell disease
  • Acute or Chronic kidney disease
  • Acute or Chronic vascular conditions, not otherwise specified
  • Active or history of inflammation of connective tissue and vascular structures (i.e. vasculitis, rheumatoid arthritis)

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Registry information

Official study title

Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells

Acronym: CEC

Important dates

Study start
2010
Primary completion
2017
Study completion
2025
First posted
Nov 2, 2009
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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