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Endothelial Cell Gene Networks of CVD

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ClinicalTrials.gov Identifier: NCT03529916
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : September 3, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Stefania lamon-Fava, Tufts University

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
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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Endothelial Cell Gene Networks of CVD
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : April 23, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Gene expression [ Time Frame: 10 weeks ]
    Gene expression [ identify relevant signature gene networks of cardiovascular disease in endothelial cells]


Biospecimen Retention:   Samples With DNA
Blood will be obtained and subjected to isolation of circulating endothelial progenitor cells using pre-specified antibody micro-beads.


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Both CVD and healthy subjects
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529916


Contacts
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Contact: Stefania Lamon-Fava, PhD 617-556-3105 stefania.lamon-fava@tufts.edu

Locations
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United States, Massachusetts
Tufts Medical Center - Cardiovascular Clinic Recruiting
Boston, Massachusetts, United States, 02111
Contact: Stefania Lamon-Fava, PhD    617-556-3105    stefania.lamon-fava@tufts.edu   
Contact: Gordon Huggins, MD       ghuggins@tuftsmedicalcenter.org   
Sponsors and Collaborators
Tufts University
Massachusetts General Hospital
Investigators
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Principal Investigator: Stefania Lamon-Fava, PhD Tufts University
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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    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases