Endothelial Cell Gene Networks of CVD

The objective of this study is to identify relevant signature gene networks of cardiovascular disease in endothelial cells derived from circulating endothelial progenitor cells of individuals with established cardiovascular disease (CVD).

Study Overview

• Status: Withdrawn
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Other: isolation of endothelial cells precursors in blood

Detailed Description

The investigators propose to enroll CVD and healthy subjects between 30 and 60 years of age, matched for age, gender, body mass index, and medication (statin and anti-hypertensive) use. Circulating endothelial progenitor cells will be isolated from blood and cultured in vitro to differentiate into endothelial cells.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center - Cardiovascular Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Both CVD and healthy subjects

Description

Inclusion Criteria for CVD subjects::

• >50% stenosis of one or more coronary arteries

Inclusion Criteria for Healthy subjects:

• absence of coronary artery stenosis

Exclusion Criteria for all subjects:

• type 2 diabetes mellitus
• chronic kidney disease,
• other chronic diseases
• dyslipidemia (fasting plasma LDL-C >160 mg/dL and triglyceride levels >150 mg/dL)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CVD subjects; CVD will be defined as >50% stenosis of one or more coronary arteries as assessed by coronary angiography.	Other: isolation of endothelial cells precursors in blood; Circulating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated.
healthy controls; healthy controls defined as not having stenosis of coronary arteries as assessed by coronary angiography.	Other: isolation of endothelial cells precursors in blood; Circulating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression	Gene expression [ identify relevant signature gene networks of cardiovascular disease in endothelial cells]	10 weeks

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Stefania Lamon-Fava, PhD, Tufts University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Anticipated): September 23, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 12841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No