Endothelial Cell Gene Networks of CVD

• Sponsor: Tufts University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03529916
• Collaborator: Massachusetts General Hospital (Other)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 40.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Endothelial Cell Gene Networks of CVD
• Actual Study Start Date: May 21, 2018
• Anticipated Primary Completion Date: Sep 23, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Gene expression [10 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center - Cardiovascular Clinic	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts University
• Massachusetts General Hospital

Investigators

• Principal Investigator: Stefania Lamon-Fava, PhD, Tufts University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefania lamon-Fava, Scientist I, Associate Professor, Tufts University
• ClinicalTrials.gov Identifier: NCT03529916
• Other Study ID Numbers: 12841
• First Posted: May 18, 2018
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Jul 28, 2021