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Endothelial Cell Gene Networks of CVD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529916
Recruitment Status : Withdrawn (No eligible participants were recruited)
First Posted : May 18, 2018
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Stefania lamon-Fava, Tufts University

Tracking Information
First Submitted Date April 23, 2018
First Posted Date May 18, 2018
Last Update Posted Date July 28, 2021
Actual Study Start Date May 21, 2018
Estimated Primary Completion Date September 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2018)
Gene expression [ Time Frame: 10 weeks ]
Gene expression [ identify relevant signature gene networks of cardiovascular disease in endothelial cells]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelial Cell Gene Networks of CVD
Official Title Endothelial Cell Gene Networks of CVD
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).
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood will be obtained and subjected to isolation of circulating endothelial progenitor cells using pre-specified antibody micro-beads.
Sampling Method Probability Sample
Study Population Both CVD and healthy subjects
Condition Coronary Heart Disease
Intervention 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.
Study Groups/Cohorts
  • CVD subjects
    CVD will be defined as >50% stenosis of one or more coronary arteries as assessed by coronary angiography.
    Intervention: 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.
    Intervention: Other: isolation of endothelial cells precursors in blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: July 27, 2021)
0
Original Estimated Enrollment
 (submitted: May 7, 2018)
20
Estimated Study Completion Date September 30, 2021
Estimated Primary Completion Date September 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03529916
Other Study ID Numbers 12841
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Stefania lamon-Fava, Tufts University
Study Sponsor Tufts University
Collaborators Massachusetts General Hospital
Investigators
Principal Investigator: Stefania Lamon-Fava, PhD Tufts University
PRS Account Tufts University
Verification Date July 2021