Coronary Heart DiseaseNCT03529916
Endothelial Cell Gene Networks of CVD
An observational study of Coronary Heart Disease, run by Tufts University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- isolation of endothelial cells precursors in blood
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Both CVD and healthy subjects
Who may be able to join
- >50% stenosis of one or more coronary arteries
- absence of coronary artery stenosis
Who cannot join
- type 2 diabetes mellitus
- chronic kidney disease,
- other chronic diseases
- dyslipidemia (fasting plasma LDL-C >160 mg/dL and triglyceride levels >150 mg/dL)
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center - Cardiovascular Clinic
Boston, Massachusetts, 02111
About this study
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).
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- isolation of endothelial cells precursors in blood
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isolation of endothelial cells precursors in bloodOther
Circulating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated.
| Study group | Role | What they receive |
|---|---|---|
| CVD subjects | CVD will be defined as >50% stenosis of one or more coronary arteries as assessed by coronary angiography. Receives: 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. Receives: Other: isolation of endothelial cells precursors in blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
Gene expression [ identify relevant signature gene networks of cardiovascular disease in endothelial cells]
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start21 May 2018
- Primary completion23 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: No eligible participants were recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Stefania lamon-Fava, Tufts University
- Investigators
- Stefania Lamon-Fava, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529916
- Sponsor's protocol ID
- 12841
- Status last verified
- Jul 2021
- First submitted
- 23 Apr 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Cell Gene Networks of CVD
- ClinicalTrials.gov ID
- NCT03529916
- Acronym / sponsor ID
- 12841
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No eligible participants were recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 21 May 2018 (actual)
- Primary completion
- 23 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVD subjects | – | Other: isolation of endothelial cells precursors in bloodCVD will be defined as >50% stenosis of one or more coronary arteries as assessed by coronary angiography. |
| healthy controls | – | Other: isolation of endothelial cells precursors in bloodhealthy controls defined as not having stenosis of coronary arteries as assessed by coronary angiography. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Both CVD and healthy subjects
Key inclusion criteria (2 listed)
- >50% stenosis of one or more coronary arteries
- absence of coronary artery stenosis
Key exclusion criteria (4 listed)
- type 2 diabetes mellitus
- chronic kidney disease,
- other chronic diseases
- dyslipidemia (fasting plasma LDL-C >160 mg/dL and triglyceride levels >150 mg/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isolation of endothelial cells precursors in bloodCirculating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated. | Other | CVD subjects, healthy controls |
Primary outcome
Gene expression
Time frame: 10 weeks
Gene expression [ identify relevant signature gene networks of cardiovascular disease in endothelial cells]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Lamon-Fava, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.