Recurrent Angina After Coronary Artery Bypass GraftVIADUCTNCT04772768
Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
An observational study of Recurrent Angina After Coronary Artery Bypass Graft and Graft Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This is a multi-center, observational cohort study including patients with prior coronary artery bypass grafting (CABG) and ≥1 saphenous vein grafts (SVG) presenting with recurrent ischemic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Recurrent Angina After Coronary Artery Bypass Graft, Graft Failure, Coronary Artery Disease Progression
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Aug 2019to 23 Jul 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent angina symptoms and a cardiac history of CABG with one or more saphenous vein grafts evaluated for saphenous vein graft dysfunction and progression of coronary artery disease in the Amsterdam University Medical Centers, Department of Cardiology
Who may be able to join
- Prior coronary artery bypass grafting
- One or more saphenous vein grafts
- Recurrent angina symptoms
Who cannot join
- <18 years of age
- ≥ 90 years of age
- Cardiogenic shock
- Pregnancy
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Centers, Department of Cardiology
Amsterdam, 1081 HV
Ruben de Winter, MD, + 31 20 444 0381, R.dewinter1@amsterdamumc.nl
About this study
Official title: Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
This is a multi-center, observational cohort study including patients with prior coronary artery bypass grafting (CABG) and ≥1 saphenous vein grafts (SVG) presenting with recurrent ischemic symptoms. Objective: to investigate the clinical outcomes in patients with prior CABG evaluated for bypass graft failure and progression of native coronary artery disease (CAD). Follow-up will be collected through national registry databases, electronic medical patient records and standardized telephonic assessment at 3 and 5 years follow-up.
Read the detailed description
Despite advances in secondary prevention, a wide variety of vascular grafts available, and evolving surgical techniques, long-term efficacy of CABG is hampered by bypass graft failure and native CAD progression. Therefore, patients with prior CABG often present with recurrent ischemic symptoms. Indeed, many prior CABG patients undergo repeat cardiac catheterization and require subsequent revascularization therapy. The clinical evaluation and diagnostic work-up of patients with recurrent angina after CABG is challenging. Patients with previous CABG are generally older, have a higher prevalence of cardiac risk factors and comorbidities, more extensive CAD, and complex atherosclerotic lesion morphology. Furthermore, current guideline recommendations on patient management are limited since post-CABG patients have often been underrepresented or excluded in large diagnostic and revascularization trials. This registry will include patients presenting with recurrent ischemic symptoms with a history of CABG and ≥1 SVGs that are referred to the Amsterdam University Medical Centers. Patients will be eligible for inclusion in the VIADUCT registry after consideration of in- and exclusion criteria. Subsequently, patients will be approached for study participation. Patients are free to refuse or to withdraw from participation in the registry at any moment. The primary objective is to investigate clinical outcomes in patients with recurrent symptoms who are evaluated for bypass graft failure and native CAD progression. In addition, results from non-invasive and invasive diagnostic tools that are used during clinical work-up to assess graft patency, the hemodynamic significance of native CAD progression, left ventricular function, and myocardial viability will be collected. We aim to evaluate the value of such tools to guide optimal repeat revascularization strategy.
- Conditions
- Recurrent Angina After Coronary Artery Bypass Graft, Graft Failure, Coronary Artery Disease Progression
- Keywords
- Coronary Artery Bypass Grafting, Recurrent angina, Saphenous vein graft dysfunction, Advanced coronary artery disease
- Medical subject headings
- Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)
Measured: 3 year follow-up
Saphenous vein graft failure
Failure rate and duration of graft patency following prior CABG procedure
Measured: At the time of referral and during subsequent 3 and 5 years follow-up
Secondary outcomes (6)
Major Adverse Cardiac Events
Components of MACE (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)
Measured: 3 and 5 years follow-up
Procedural success and mortality in patients who underwent percutaneous coronary intervention of a saphenous vein graft
Procedural success defined by technical success and no major in-hospital complications (mortality, stroke, myocardial infarction, tamponade requiring centesis, emergency CABG/PCI, acute kidney failure requiring dialysis, vascular access site complication or major bleeding requiring transfusion or surgery)
Measured: In hospital and during subsequent 3 and 5 years follow-up
Procedural success and mortality in patients who underwent percutaneous coronary intervention of a (bypassed) native coronary artery
Procedural success defined by technical success and no major in-hospital complications (mortality, stroke, myocardial infarction, tamponade requiring centesis, emergency CABG/PCI, acute kidney failure requiring dialysis, vascular access site complication or major bleeding requiring transfusion or surgery)
Measured: In hospital and during subsequent 3 and 5 years follow-up
Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale
Canadian Cardiovascular Society (CCS) Grading Scale measures whether patient have angina pectoris complaints, and to what extent patients experienced this. It uses a scale of 1-4 where 1 means angina pectoris (chest pain) only occurs with strenuous, rapid or prolonged exertion, and 4 means angina is present during little physical effort or even during rest.
Measured: At baseline and during subsequent 3 and 5 years follow-up
Quality of life assessed by Rose dyspnea scale questionnaire (RDS)
Rose dyspnea scale questionnaire (RDS) measures dyspnea complaints, or shortness of breath. It consists of 4 questions about dyspnea complaints in the everyday life of patients. For every patient, a score is compiled of the highest limitation in daily life, resulting in a score of 0-4, where 0 means no dyspnea complaints and 4 means the patient has complaints during no or minimal physical effort.
Measured: At baseline and during subsequent 3 and 5 years follow-up
Composite score of quality of life
Composite of all quality of life questionnaires, where all outcomes are summed to provide a total score
Measured: At baseline and during subsequent 3 and 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start23 Aug 2019
- Primary completion23 Jul 2024 (estimated)
- Study completion23 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Angina After Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Knaapen, Amsterdam UMC, location VUmc
- Investigators
- Paul Knaapen, Professor, Principal investigator, Amsterdam University Medical Centers, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772768
- Sponsor's protocol ID
- Amsterdam UMC 2019.457
- Acronym
- VIADUCT
- Status last verified
- May 2023
- First submitted
- 22 Feb 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoek R, de Winter RW, Peters RT, Somsen YBO, van Diemen PA, Jukema RA, Twisk JW, Verouden NJ, den Hartog AW, Raijmakers PG, Nap A, Danad I, Knaapen P. Comparison of Fractional Flow Reserve and Myocardial Perfusion Imaging in Saphenous Vein Grafts. Catheter Cardiovasc Interv. 2025 May;105(6):1365-1374. doi: 10.1002/ccd.31467. Epub 2025 Feb 24.
PubMed 39991799
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
- ClinicalTrials.gov ID
- NCT04772768
- Acronym / sponsor ID
- VIADUCT / Amsterdam UMC 2019.457
- Conditions
- Recurrent Angina After Coronary Artery Bypass Graft, Graft Failure, Coronary Artery Disease Progression
- Keywords
- Coronary Artery Bypass Grafting, Recurrent angina, Saphenous vein graft dysfunction, Advanced coronary artery disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 23 Jul 2024 (estimated)
- Study completion
- 23 Jul 2029 (estimated)
- First posted
- 26 Feb 2021 (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 multi-center, observational cohort study including patients with prior coronary artery bypass grafting (CABG) and ≥1 saphenous vein grafts (SVG) presenting with recurrent ischemic symptoms. Objective: to investigate the clinical outcomes in patients with prior CABG evaluated for bypass graft failure and progression of native coronary artery disease (CAD). Follow-up will be collected through national registry databases, electronic medical patient records and standardized telephonic assessment at 3 and 5 years follow-up.
Detailed description
Despite advances in secondary prevention, a wide variety of vascular grafts available, and evolving surgical techniques, long-term efficacy of CABG is hampered by bypass graft failure and native CAD progression. Therefore, patients with prior CABG often present with recurrent ischemic symptoms. Indeed, many prior CABG patients undergo repeat cardiac catheterization and require subsequent revascularization therapy. The clinical evaluation and diagnostic work-up of patients with recurrent angina after CABG is challenging. Patients with previous CABG are generally older, have a higher prevalence of cardiac risk factors and comorbidities, more extensive CAD, and complex atherosclerotic lesion morphology. Furthermore, current guideline recommendations on patient management are limited since post-CABG patients have often been underrepresented or excluded in large diagnostic and revascularization trials. This registry will include patients presenting with recurrent ischemic symptoms with a history of CABG and ≥1 SVGs that are referred to the Amsterdam University Medical Centers. Patients will be eligible for inclusion in the VIADUCT registry after consideration of in- and exclusion criteria. Subsequently, patients will be approached for study participation. Patients are free to refuse or to withdraw from participation in the registry at any moment. The primary objective is to investigate clinical outcomes in patients with recurrent symptoms who are evaluated for bypass graft failure and native CAD progression. In addition, results from non-invasive and invasive diagnostic tools that are used during clinical work-up to assess graft patency, the hemodynamic significance of native CAD progression, left ventricular function, and myocardial viability will be collected. We aim to evaluate the value of such tools to guide optimal repeat revascularization strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent angina symptoms and a cardiac history of CABG with one or more saphenous vein grafts evaluated for saphenous vein graft dysfunction and progression of coronary artery disease in the Amsterdam University Medical Centers, Department of Cardiology
Key inclusion criteria (3 listed)
- Prior coronary artery bypass grafting
- One or more saphenous vein grafts
- Recurrent angina symptoms
Key exclusion criteria (5 listed)
- <18 years of age
- ≥ 90 years of age
- Cardiogenic shock
- Pregnancy
- Failure to provide informed consent
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
Major adverse cardiovascular events (MACE)
Time frame: 3 year follow-up
The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)
Saphenous vein graft failure
Time frame: At the time of referral and during subsequent 3 and 5 years follow-up
Failure rate and duration of graft patency following prior CABG procedure
6 secondary outcomes
Major Adverse Cardiac Events
Time frame: 3 and 5 years follow-up
Procedural success and mortality in patients who underwent percutaneous coronary intervention of a saphenous vein graft
Time frame: In hospital and during subsequent 3 and 5 years follow-up
Procedural success and mortality in patients who underwent percutaneous coronary intervention of a (bypassed) native coronary artery
Time frame: In hospital and during subsequent 3 and 5 years follow-up
Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale
Time frame: At baseline and during subsequent 3 and 5 years follow-up
Quality of life assessed by Rose dyspnea scale questionnaire (RDS)
Time frame: At baseline and during subsequent 3 and 5 years follow-up
Composite score of quality of life
Time frame: At baseline and during subsequent 3 and 5 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Derived from this study: PubMed 39991799Hoek R, de Winter RW, Peters RT, Somsen YBO, van Diemen PA, Jukema RA, Twisk JW, Verouden NJ, den Hartog AW, Raijmakers PG, Nap A, Danad I, Knaapen P. Comparison of Fractional Flow Reserve and Myocardial Perfusion Imaging in Saphenous Vein Grafts. Catheter Cardiovasc Interv. 2025 May;105(6):1365-1374. doi: 10.1002/ccd.31467. Epub 2025 Feb 24.
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.
Paul Knaapen, Professor principal investigator
Amsterdam University Medical Centers, Department of Cardiology
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 Recurrent Angina After Coronary Artery Bypass Graft and Graft Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Jun 2023. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Knaapen, Professor (+31 20 444 0123, p.knaapen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: 3 year follow-up). 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?
On the ClinicalTrials.gov record for NCT04772768, which also lists 1 linked publication.
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 2 Jun 2023.