Clinical trial NCT04772768: Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
Official title: Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 3 year follow-up
measure: Saphenous vein graft failure
timeFrame: At the time of referral and during subsequent 3 and 5 years follow-up
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 3 and 5 years follow-up
measure: Procedural success and mortality in patients who underwent percutaneous coronary intervention of a saphenous vein graft
timeFrame: In hospital and during subsequent 3 and 5 years follow-up
measure: Procedural success and mortality in patients who underwent percutaneous coronary intervention of a (bypassed) native coronary artery
timeFrame: In hospital and during subsequent 3 and 5 years follow-up
measure: Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale
timeFrame: At baseline and during subsequent 3 and 5 years follow-up
measure: Quality of life assessed by Rose dyspnea scale questionnaire (RDS)
timeFrame: At baseline and during subsequent 3 and 5 years follow-up
measure: Composite score of quality of life
timeFrame: At baseline and during subsequent 3 and 5 years follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers, Department of Cardiology
Study officials:
affiliation: Amsterdam University Medical Centers, Department of Cardiology
name: Paul Knaapen, Professor
role: PRINCIPAL_INVESTIGATOR
References: