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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03529916
Other study ID # 12841
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date May 21, 2018
Est. completion date September 30, 2021

Study information

Verified date July 2021
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 30, 2021
Est. primary completion date September 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 60 Years
Eligibility 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 Design


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.

Locations

Country Name City State
United States Tufts Medical Center - Cardiovascular Clinic Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Tufts University Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gene expression Gene expression [ identify relevant signature gene networks of cardiovascular disease in endothelial cells] 10 weeks
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