Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease

Graft Failure Clinical Trial

— VIADUCT  

Official title:

Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04772768
• Other study ID #: Amsterdam UMC 2019.457
• Status: Recruiting
• Start date: August 23, 2019
• Est. completion date: July 23, 2029

Study information

• Verified date: May 2023
• Source: Amsterdam UMC, location VUmc
• Contact: Paul Knaapen, Professor
• Phone: +31 20 444 0123
• Email: p.knaapen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 23, 2029
• Est. primary completion date: July 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Prior coronary artery bypass grafting
• One or more saphenous vein grafts
• Recurrent angina symptoms

Exclusion Criteria:

• <18 years of age
• = 90 years of age
• Cardiogenic shock
• Pregnancy
• Failure to provide informed consent

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Progression
• Coronary Disease
• Disease Progression
• Graft Failure
• Myocardial Ischemia
• Recurrent Angina After Coronary Artery Bypass Graft

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Centers, Department of Cardiology	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 year follow-up
Primary	Saphenous vein graft failure	Failure rate and duration of graft patency following prior CABG procedure	At the time of referral and during subsequent 3 and 5 years follow-up
Secondary	Major Adverse Cardiac Events	Components of MACE (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)	3 and 5 years follow-up
Secondary	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)	In hospital and during subsequent 3 and 5 years follow-up
Secondary	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)	In hospital and during subsequent 3 and 5 years follow-up
Secondary	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.	At baseline and during subsequent 3 and 5 years follow-up
Secondary	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.	At baseline and during subsequent 3 and 5 years follow-up
Secondary	Composite score of quality of life	Composite of all quality of life questionnaires, where all outcomes are summed to provide a total score	At baseline and during subsequent 3 and 5 years follow-up