Endothelial Cell Gene Networks of CVD

NCT03529916 | Withdrawn

• 1 other identifier: 12841
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Gene expression

  Gene expression \[ identify relevant signature gene networks of cardiovascular disease in endothelial cells\]

  10 weeks

Study Arms (2)

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

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

Interventions

isolation of endothelial cells precursors in blood OTHER

Circulating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated.

CVD subjects; healthy controls

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Both CVD and healthy subjects

You may qualify if:

• \>50% stenosis of one or more coronary arteries
• absence of coronary artery stenosis

You may not qualify if:

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

Sponsors & Collaborators

• Tufts University: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Tufts Medical Center - Cardiovascular Clinic

Boston, Massachusetts, 02111, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be obtained and subjected to isolation of circulating endothelial progenitor cells using pre-specified antibody micro-beads.

MeSH Terms

Conditions

Coronary Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stefania Lamon-Fava, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist I, Associate Professor

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 18, 2018
• Study Start: May 21, 2018
• Primary Completion: September 23, 2021
• Study Completion: September 30, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)