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

NCT ID: NCT04772768

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2029-07-23

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.

Conditions

Recurrent Angina After Coronary Artery Bypass Graft; Graft Failure; Coronary Artery Disease Progression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Paul Knaapen

Principle investigator, MD, PhD, Professor of Cardiac Intervention and Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Knaapen, Professor

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Centers, Department of Cardiology

Locations

Amsterdam University Medical Centers, Department of Cardiology

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Paul Knaapen, Professor

Role: CONTACT

p.knaapen@amsterdamumc.nl

+31 20 444 0123

Ruben de Winter, MD

Role: CONTACT

r.dewinter1@amsterdamumc.nl

+ 31 20 444 0381

Facility Contacts

Ruben de Winter, MD

Role: primary

R.dewinter1@amsterdamumc.nl

+ 31 20 444 0381

References

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.

Reference Type: DERIVED

PMID: 39991799 (View on PubMed)

Other Identifiers

Amsterdam UMC 2019.457

Identifier Type: -

Identifier Source: org_study_id