Molecular and Morphologic Characterization of Circulating Endothelial Cells

Acute Myocardial Infarction Clinical Trial

— CEC  

Official title:

Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01005485
• Other study ID #: IRB#09-5287
• Status: Active, not recruiting
• Start date: January 2010
• Est. completion date: December 2025

Study information

• Verified date: March 2021
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 664
• Est. completion date: December 2025
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Scrippshealth	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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