Multivessel Coronary Artery DiseasePhase 4CABGRevolutionNCT03851276
A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on MSCT Imaging Utilizing GE Healthcare Revolution CT and HeartFlow FFRCT.
A Phase 4 study testing Multi-sliced computed tomography (MSCT) in people with Multivessel Coronary Artery Disease, run by ECRI bv at 4 sites in 4 countries.
Trial summary
The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease
- What is being tested?
- Multi-sliced computed tomography (MSCT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 28 Jun 2019to 30 Mar 2020
- Phase
- Phase 4
- 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
- Patient referred to CABG treatment (as assessed by 'conventional Heart Team');
- Patients with at least 1 stenosis (visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) supplying viable myocardium with or without left main involvement;
- Patients with hypoplastic right coronary artery (RCA) with absence of descending posterior and presence of a lesion in the LAD and circumflex (CX)territories may be included in the trial as a 3vessel disease equivalent. Ostial LAD plus ostial left circumflex artery (LCX) may be included in the trial as a Left Main equivalent
- Distal vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;
- Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normalized (stable or decreasing) cardiac biomarker values Note: For patients showing elevated Troponin (cTn) (e.g. non-STEMI patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to the CABG procedure to confirm that: • hs-cTn or Troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped • CK-MB and CK levels are within normal range If hs-cTn or Troponin I or T levels are stable or have dropped, or the Creatine kinase-MB (CK-MB) and Creatine kinase (CK) levels are within normal ranges, and the ECG is normal, the patient may be included in the study.
- All anatomical SYNTAX Scores are eligible;
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- Patient amenable to a MSCT coronary angiography (e.g. no claustrophobia, high heartrate not amenable to beta-blockers, poor renal function, etc., up to discretion of investigator);
- Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site;
- The patient agrees to the 1-month follow-up visit including a MSCT coronary angiography.
Who cannot join
- Under the age of 18 years;
- Unable to give Informed Consent;
- Known pregnancy at time of enrollment. Female of childbearing potential i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause). Female who is breastfeeding at time of enrollment;
- Prior percutaneous coronary intervention (PCI) or CABG; history of coronary stent implantation;
- Evidence of evolving or ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice);
- Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment);
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- Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement) and/or aneurysmectomy;
- Single or two-vessel disease (at time of the conventional Heart Team consensus);
- Non-graftable distal bed in >1 vessel as assessed by the surgeon based on conventional angiography;
- Atrial fibrillation or significant arrhythmias;
- Known allergy to iodinated contrast;
- A Body Mass Index (BMI) of 35 or greater;
- Currently participating in another trial and not yet at its primary endpoint.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Multicentre, Single Arm Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on Non-invasive MSCT Angiography Imaging Utilizing High-definition GE Healthcare RevolutionTM CT and HeartFlow FFRCT.
The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Surgical revascularization strategy and treatment planning will be solely based on MSCT (with FFRCT) without knowledge of the anatomy defined by conventional cine-angiography.
Read the detailed description
The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Surgical revascularization strategy and treatment planning will be solely based on MSCT (with FFRCT) without knowledge of the anatomy defined by conventional cine-angiography.
One clinical follow-up visit including MSCT acquisition will be performed at 30 days after bypass surgery in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging.
- Conditions
- Multivessel Coronary Artery Disease
- Being tested
- Multi-sliced computed tomography (MSCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-sliced computed tomography (MSCT)Radiation
Surgery planning done based solely on MSCT.
| Study group | Role | What they receive |
|---|---|---|
| Patients with 3-vessels diseased referred to CABG surgery | Other | Patients with 3-vessel disease (with or without left main involvement) for which the regular and conventional Heart Team has made already the decision to refer the patient for CABG treatment. Receives: Radiation: Multi-sliced computed tomography (MSCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in the intention to treat (ITT) population for whom CABG planning and execution was based solely on MSCT.
Measured: 2 weeks after enrollment
Number of graft/anastomoses for which graft/anastomosis stenosis (≥50%DS - 99%DS) or occlusion (100%DS) occurred as percentage of the total number of intra graft/anastomoses.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start28 Jun 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Why it stopped: Administrative issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multivessel Coronary Artery 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECRI bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare, HeartFlow, Inc.
- Responsible party
- Sponsor
- Investigators
- Patrick W Serruys, Prof. dr., Study chair, NHLI Imperial College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851276
- Sponsor's protocol ID
- ECRI-12
- Acronym
- CABGRevolution
- Status last verified
- Dec 2019
- First submitted
- 12 Feb 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy. Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Single Arm Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on Non-invasive MSCT Angiography Imaging Utilizing High-definition GE Healthcare RevolutionTM CT and HeartFlow FFRCT.
- ClinicalTrials.gov ID
- NCT03851276
- Acronym / sponsor ID
- CABGRevolution / ECRI-12
- Conditions
- Multivessel Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ECRI bvIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare, HeartFlow, Inc.
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 22 Feb 2019 (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 CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Surgical revascularization strategy and treatment planning will be solely based on MSCT (with FFRCT) without knowledge of the anatomy defined by conventional cine-angiography.
Detailed description
The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Surgical revascularization strategy and treatment planning will be solely based on MSCT (with FFRCT) without knowledge of the anatomy defined by conventional cine-angiography.
One clinical follow-up visit including MSCT acquisition will be performed at 30 days after bypass surgery in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with 3-vessels diseased referred to CABG surgery | Other | Radiation: Multi-sliced computed tomography (MSCT)Patients with 3-vessel disease (with or without left main involvement) for which the regular and conventional Heart Team has made already the decision to refer the patient for CABG treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient referred to CABG treatment (as assessed by 'conventional Heart Team');
- Patients with at least 1 stenosis (visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) supplying viable myocardium with or without left main involvement;
- Patients with hypoplastic right coronary artery (RCA) with absence of descending posterior and presence of a lesion in the LAD and circumflex (CX)territories may be included in the trial as a 3vessel disease equivalent. Ostial LAD plus ostial left circumflex artery (LCX) may be included in the trial as a Left Main equivalent
- Distal vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;
- Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normalized (stable or decreasing) cardiac biomarker values Note: For patients showing elevated Troponin (cTn) (e.g. non-STEMI patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to the CABG procedure to confirm that: • hs-cTn or Troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped • CK-MB and CK levels are within normal range If hs-cTn or Troponin I or T levels are stable or have dropped, or the Creatine kinase-MB (CK-MB) and Creatine kinase (CK) levels are within normal ranges, and the ECG is normal, the patient may be included in the study.
Key exclusion criteria (13 listed)
- Under the age of 18 years;
- Unable to give Informed Consent;
- Known pregnancy at time of enrollment. Female of childbearing potential i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause). Female who is breastfeeding at time of enrollment;
- Prior percutaneous coronary intervention (PCI) or CABG; history of coronary stent implantation;
- Evidence of evolving or ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice);
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 |
|---|---|---|
| Multi-sliced computed tomography (MSCT)Surgery planning done based solely on MSCT. | Radiation | Patients with 3-vessels diseased referred to CABG surgery |
Primary outcome
Percentage of patients in the intention to treat (ITT) population for whom CABG planning and execution was based solely on MSCT.
Time frame: 2 weeks after enrollment
Number of graft/anastomoses for which graft/anastomosis stenosis (≥50%DS - 99%DS) or occlusion (100%DS) occurred as percentage of the total number of intra graft/anastomoses.
Time frame: 1 month after surgery
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 6 Dec 2019.
- Individual participant dataSharing planned: Undecided. The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy. Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.
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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.
Patrick W Serruys, Prof. dr. study chair
NHLI Imperial College, London
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multi-sliced computed tomography (MSCT) in people with Multivessel Coronary Artery Disease, run by ECRI bv at 4 sites in 4 countries.
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 9 inclusion and 13 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Germany, Italy, Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of patients in the intention to treat (ITT) population for whom CABG planning and execution was based solely on MSCT. (time frame: 2 weeks after enrollment). The study lists 2 primary outcomes in all. 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 6 Dec 2019.