Coronary Heart DiseaseREVASCNCT01924962
Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries
A study testing revascularisation in people with Coronary Heart Disease, run by University Heart Center Freiburg - Bad Krozingen at 1 site in Germany.
Trial summary
The study is a randomised comparison of recanalisation of chronic occluded coronary arteries with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and scar-size are determinated by using magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- revascularisation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteGermany
- Study dates
- 28 May 2008to 16 Jun 2017
- Phase
- Interventional
- 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
Who may be able to join
- chronic total occlusion with thrombolysis in myocardial infarction (TIMI) 0 flow (or distal capillary reflow) of a native coronary artery with an estimated reference vessel diameter of 2.5 to 4.0 mm
- chronic total occlusion has more than 4 weeks duration
- the target vessel has not previously been treated with percutaneous coronary intervention
- the target vessel must be feasible for stent implantation
- patient has stable or unstable angina pectoris or a positive functional study for ischemia
- patient must be 18 years of age or older
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- female subjects of childbearing age must have a negative pregnancy test within 7 days before procedure
- patient has been informed of the nature of the study and agrees to its
- provisions ans has written informed consent as approved by the Ethics Committee
- patient complies with all required post-procedure follow-up
Who cannot join
- a documented left ventricular function < 30%
- patient has a acute myocardial infarction (>3x normal creatine kinase (CK with presence of CK-MB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure
- patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel or contrast media that cannot be adequately been pre-medicated
- patient has a platelet count of < 100000 cells/mm3 or > 700000 cells/m3, a white blood cell count of < 3000 cells/mm3 or documented or suspected liver disease
- patient has a history of bleeding diathesis or coagulopathy
- patient has suffered a cerebrovascular accident or transient ischemic attack within the past 6 months
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- active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
- patients has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life-expectancy (less than 2 years)
- the target vessel contains intraluminal thrombus
- the target vessel or lesson shows angiographic evidence of severe calcification
- patient has contraindications to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitäts Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189
About this study
Official title: A Randomized Comparison of Recanalisation With Implantation of Cypher Sirolimus Eluting Coronary Stents and Medical Therapy
The study is a randomised comparison of recanalisation of chronic occluded coronary arteries with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the superiority of medical therapy over revascularisation.
Read the detailed description
In the REVASC-study recovery of left ventricular function after recanalization of chronic total coronary occlusions (CTO) and implantation of sirolimus-eluting stents will be examined and compared to medical treatment. Extent of the scar, viable myocardium in the infarct zone and regional left ventricular function will be assessed by cardiac magnetic resonance. Patients with regional systolic left ventricular dysfunction of any degree in the supply territory of the CTO vessel will be randomized to either recanalization of the occluded coronary artery or to conservative therapy. It is of interest whether CTO patients will have an improvement in left ventricular function after late coronary reopening, regarding the high technical demands and costs of CTO recanalization.
- Conditions
- Coronary Heart Disease
- Being tested
- revascularisation
- Keywords
- chronic occlusion of coronary artery, left ventricular function, revascularisation
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revascularisationDevice
Also called Cypher-stent
revascularisation of chronic occluded coronary artery
| Study group | Role | What they receive |
|---|---|---|
| medical therapy | No intervention | patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed. |
| revascularisation | Active comparator | revascularisation and stent-implantation of chronic occluded coronary artery Receives: Device: revascularisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in regional left ventricular function at 9 months
Improvement of the left ventricular function in the territory of the chronically occluded coronary artery assessed by magnetic resonance imaging before revascularisation and at 9 months post-procedure. For regional left ventricular analysis, wall thickening and systolic inward motion will be determined in 12 segments in all short axis slices by the modified centerline method.
Measured: 9 months
Secondary outcomes (2)
Change from baseline in global left ventricular function at 6 months
Improvement of global left ventricular function (assessed by magnetic resonance imaging at baseline and 9 months post-procedure. For global left ventricular analysis, all short-axis slices from the apex to the base will be assessed. By planimetry of all short-axis views, left ventricular end-systolic volume (in milliliters), left ventricular end-diastolic volume (in milliliters), and ejection fraction (in percent) will be determined.
Measured: 6 months
Changes from baseline in left ventricular volume at 6 months
Changes in diastolic and systolic volume indices (assessed by magnetic resonance imaging at baseline and 9 months post-procedure)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study start28 May 2008
- Primary completion14 Aug 2016
- Study completion16 Jun 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Heart Center Freiburg - Bad Krozingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Heinz Joachim Buettner, University Heart Center Freiburg - Bad Krozingen
- Investigators
- Heinz Joachim Buettner, MD, Principal investigator, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924962
- Sponsor's protocol ID
- BK 1-2011
- Acronym
- REVASC
- Status last verified
- Nov 2017
- First submitted
- 15 Aug 2013
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Recanalisation With Implantation of Cypher Sirolimus Eluting Coronary Stents and Medical Therapy
- ClinicalTrials.gov ID
- NCT01924962
- Acronym / sponsor ID
- REVASC / BK 1-2011
- Conditions
- Coronary Heart Disease
- Keywords
- chronic occlusion of coronary artery, left ventricular function, revascularisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University Heart Center Freiburg - Bad KrozingenUniversity, hospital or other
- Study start
- 28 May 2008 (actual)
- Primary completion
- 14 Aug 2016 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 19 Aug 2013 (estimated)
- 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 study is a randomised comparison of recanalisation of chronic occluded coronary arteries with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the superiority of medical therapy over revascularisation.
Detailed description
In the REVASC-study recovery of left ventricular function after recanalization of chronic total coronary occlusions (CTO) and implantation of sirolimus-eluting stents will be examined and compared to medical treatment. Extent of the scar, viable myocardium in the infarct zone and regional left ventricular function will be assessed by cardiac magnetic resonance. Patients with regional systolic left ventricular dysfunction of any degree in the supply territory of the CTO vessel will be randomized to either recanalization of the occluded coronary artery or to conservative therapy. It is of interest whether CTO patients will have an improvement in left ventricular function after late coronary reopening, regarding the high technical demands and costs of CTO recanalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical therapy | No intervention | –patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed. |
| revascularisation | Active comparator | Device: revascularisationrevascularisation and stent-implantation of chronic occluded coronary artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- chronic total occlusion with thrombolysis in myocardial infarction (TIMI) 0 flow (or distal capillary reflow) of a native coronary artery with an estimated reference vessel diameter of 2.5 to 4.0 mm
- chronic total occlusion has more than 4 weeks duration
- the target vessel has not previously been treated with percutaneous coronary intervention
- the target vessel must be feasible for stent implantation
- patient has stable or unstable angina pectoris or a positive functional study for ischemia
Key exclusion criteria (11 listed)
- a documented left ventricular function < 30%
- patient has a acute myocardial infarction (>3x normal creatine kinase (CK with presence of CK-MB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure
- patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel or contrast media that cannot be adequately been pre-medicated
- patient has a platelet count of < 100000 cells/mm3 or > 700000 cells/m3, a white blood cell count of < 3000 cells/mm3 or documented or suspected liver disease
- patient has a history of bleeding diathesis or coagulopathy
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 |
|---|---|---|
| revascularisationAlso: Cypher-stentrevascularisation of chronic occluded coronary artery | Device | revascularisation |
Primary outcome
Changes from baseline in regional left ventricular function at 9 months
Time frame: 9 months
Improvement of the left ventricular function in the territory of the chronically occluded coronary artery assessed by magnetic resonance imaging before revascularisation and at 9 months post-procedure. For regional left ventricular analysis, wall thickening and systolic inward motion will be determined in 12 segments in all short axis slices by the modified centerline method.
2 secondary outcomes
Change from baseline in global left ventricular function at 6 months
Time frame: 6 months
Changes from baseline in left ventricular volume at 6 months
Time frame: 6 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 7 Nov 2017.
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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.
Heinz Joachim Buettner, MD principal investigator
Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing revascularisation in people with Coronary Heart Disease, run by University Heart Center Freiburg - Bad Krozingen at 1 site in Germany.
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 10 inclusion and 11 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 7 Nov 2017. 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 Germany. 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 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?
Changes from baseline in regional left ventricular function at 9 months (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 7 Nov 2017.