Stable AnginaREVERNCT03214900
Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation
An observational study of Stable Angina, run by Hospital San Carlos, Madrid.
Trial summary
This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the correlation between the change (baseline vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 31 Dec 2016
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stable angina
Who may be able to join
- Patients who present stable angina, silent ischemia or unstable angina whenever there is no elevation of markers of myocardial damage above the limit of normality
- Presence of at least one severe coronary stenosis (> 70% by visual analysis), susceptible of percutaneous treatment with stent implantation and an optical coherence Tomography study
- All patients should be taking statins at least 2 months prior to their inclusion in the study.
Who cannot join
- Age under 18 years and pregnant or fertile age,
- Patients with ST-elevation myocardial infarction or non-ST-elevation acute coronary syndrome with markers of recent myocardial damage (<3 months),
- Patients in whom a drug-eluting stent and a bare stent have been implanted in the same procedure.
- Percutaneous treatment of restenotic lesions or total chronic occlusions.
- The use of stent pre-implantation ablation techniques (rotablator, directional atherectomy).
- Chronic renal insufficiency with serum creatinine greater than or equal to 2.5.
Show all 12Show fewer
- Coronary revascularization in previous 3 months.
- Severe ventricular dysfunction (<25%).
- Major trauma or surgery in the previous 3 months.
- Previous organ transplantation, active neoplastic process or inflammatory disease, treatment with immunosuppressors.
- Contraindication or allergy to thienopyridines.
- Life expectancy less than one year.
About this study
Official title: Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation and the Development of Neointimal Hyperplasia and Stent Restenosis (REVER Trial).
This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the correlation between the change (baseline vs. 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence tomography
Read the detailed description
For the purpose of the study, flow cytometry analyses will be performed before intervention, at 1 week, 1 month and 9 months. In addition, cell functionality analyses will be performed by quantification of colony forming units, aldehidrodehidrogenase activity, cell proliferation by WST-1 and senescence by !-galactosidase enzyme. At 9 months the degree of neointimal proliferation will be measured by optical coherence tomography . A clinical follow-up will be performed at 1 year. Secondary endpoints include: 1. to correlate the change in the number and cell functionality of circulation progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography, and the percentage of non covered struts by optical coherence tomography at 9 months.
2.-. To evaluate the role of other subtypes of cells CD 133+/Kinase Insert Domain Receptor (KDR+), CD 14+, mesenchymal stem cells, endothelial cell markers (VE cadherina, P1H12), integrin expression of Macrophage-1 antigen (MAC-1) and the development of neointimal hyperplasia.
- Conditions
- Stable Angina
- Medical subject headings
- Angina, Stable
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between the change (baseline vs 1 week) of circulating with neointimal hyperplasia endothelial progenitor cells and in cell functionality following an Everolimus eluting stent implantation with the grade of neointimal hyperplasia
Correlation between the change (baseline vs 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
Measured: 9 months
Secondary outcomes (5)
to correlate number of cell and functionality of progenitor cells and injury score following everolimus eluting stent
to correlate the number and cell functionality of progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography
Measured: baseline
to evaluate other subtypes of cells with neointimal hyperplasia
To evaluate the role of other subtypes of cells CD 133+/KDR+, following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
Measured: 9 months
to evaluate other subtypes of cells with neointimal hyperplasia
the role of other subtypes of cells CD 14+ following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
Measured: 9 months
to evaluate endothelial cell markers with neointimal hyperplasia
the role of endothelial cell markers (VE cadherin, P1H12) following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
Measured: 9 months
to evaluate integrin expression of MAC-1 (Macrophage-1 antigen) with neointimal hyperplasia
the role of integrin expression of MAC-1(Macrophage-1 antigen) following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Jul 2012
- Primary completion1 Jul 2014
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Pilar Jimenez Quevedo, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214900
- Sponsor's protocol ID
- PI11/00299
- Acronym
- REVER
- Status last verified
- Jul 2017
- First submitted
- 25 Jun 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation and the Development of Neointimal Hyperplasia and Stent Restenosis (REVER Trial).
- ClinicalTrials.gov ID
- NCT03214900
- Acronym / sponsor ID
- REVER / PI11/00299
- Conditions
- Stable Angina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 12 Jul 2017 (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.
This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the correlation between the change (baseline vs. 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence tomography
Detailed description
For the purpose of the study, flow cytometry analyses will be performed before intervention, at 1 week, 1 month and 9 months. In addition, cell functionality analyses will be performed by quantification of colony forming units, aldehidrodehidrogenase activity, cell proliferation by WST-1 and senescence by !-galactosidase enzyme. At 9 months the degree of neointimal proliferation will be measured by optical coherence tomography . A clinical follow-up will be performed at 1 year. Secondary endpoints include: 1. to correlate the change in the number and cell functionality of circulation progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography, and the percentage of non covered struts by optical coherence tomography at 9 months.
2.-. To evaluate the role of other subtypes of cells CD 133+/Kinase Insert Domain Receptor (KDR+), CD 14+, mesenchymal stem cells, endothelial cell markers (VE cadherina, P1H12), integrin expression of Macrophage-1 antigen (MAC-1) and the development of neointimal hyperplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stable angina
Key inclusion criteria (3 listed)
- Patients who present stable angina, silent ischemia or unstable angina whenever there is no elevation of markers of myocardial damage above the limit of normality
- Presence of at least one severe coronary stenosis (> 70% by visual analysis), susceptible of percutaneous treatment with stent implantation and an optical coherence Tomography study
- All patients should be taking statins at least 2 months prior to their inclusion in the study.
Key exclusion criteria (12 listed)
- Age under 18 years and pregnant or fertile age,
- Patients with ST-elevation myocardial infarction or non-ST-elevation acute coronary syndrome with markers of recent myocardial damage (<3 months),
- Patients in whom a drug-eluting stent and a bare stent have been implanted in the same procedure.
- Percutaneous treatment of restenotic lesions or total chronic occlusions.
- The use of stent pre-implantation ablation techniques (rotablator, directional atherectomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between the change (baseline vs 1 week) of circulating with neointimal hyperplasia endothelial progenitor cells and in cell functionality following an Everolimus eluting stent implantation with the grade of neointimal hyperplasia
Time frame: 9 months
Correlation between the change (baseline vs 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography
5 secondary outcomes
to correlate number of cell and functionality of progenitor cells and injury score following everolimus eluting stent
Time frame: baseline
to evaluate other subtypes of cells with neointimal hyperplasia
Time frame: 9 months
to evaluate other subtypes of cells with neointimal hyperplasia
Time frame: 9 months
to evaluate endothelial cell markers with neointimal hyperplasia
Time frame: 9 months
to evaluate integrin expression of MAC-1 (Macrophage-1 antigen) with neointimal hyperplasia
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina, run by Hospital San Carlos, Madrid.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The correlation between the change (baseline vs 1 week) of circulating with neointimal hyperplasia endothelial progenitor cells and in cell functionality following an Everolimus eluting stent implantation with the grade of neointimal hyperplasia (time frame: 9 months). 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 18 Jul 2017.