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NCT Number: NCT04772768

Prior CABG Patients 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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Medical Centers, Department of Cardiology

Amsterdam, 1081 HV, Netherlands

Location status: Recruiting

Location contact

Ruben de Winter, MD

CONTACT

[email protected]

+ 31 20 444 0381

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Major Adverse Cardiac Events

    Time frame: 3 and 5 years follow-up

    Components of MACE (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)

  2. 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 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)

  3. 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

    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)

  4. 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

    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.

  5. Quality of life assessed by Rose dyspnea scale questionnaire (RDS)

    Time frame: At baseline and during subsequent 3 and 5 years follow-up

    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.

  6. Composite score of quality of life

    Time frame: At baseline and during subsequent 3 and 5 years follow-up

    Composite of all quality of life questionnaires, where all outcomes are summed to provide a total score

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Knaapen, Professor

CONTACT

[email protected]

+31 20 444 0123

Ruben de Winter, MD

CONTACT

[email protected]

+ 31 20 444 0381

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Acronym: VIADUCT

Important dates

Study start
2019
Primary completion
2024
Study completion
2029
First posted
Feb 26, 2021
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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