NCT04772768

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Aug 2019Jul 2029

Study Start

First participant enrolled

August 23, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2029

Expected
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

4.9 years

First QC Date

February 22, 2021

Last Update Submit

May 30, 2023

Conditions

Recurrent Angina After Coronary Artery Bypass GraftGraft FailureCoronary Artery Disease Progression

Keywords

Coronary Artery Bypass GraftingRecurrent anginaSaphenous vein graft dysfunctionAdvanced coronary artery disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Major Adverse Cardiac Events

    3 and 5 years follow-up

  • Procedural success and mortality in patients who underwent percutaneous coronary intervention of a saphenous vein graft

    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

    In hospital and during subsequent 3 and 5 years follow-up

  • Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale

    At baseline and during subsequent 3 and 5 years follow-up

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

    At baseline and during subsequent 3 and 5 years follow-up

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Centers, Department of Cardiology

Amsterdam, 1081 HV, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39991799DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Knaapen, Professor

    Amsterdam University Medical Centers, Department of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Knaapen, Professor

CONTACT

+31 20 444 0123p.knaapen@amsterdamumc.nl

Ruben de Winter, MD

CONTACT

+ 31 20 444 0381r.dewinter1@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator, MD, PhD, Professor of Cardiac Intervention and Imaging

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 26, 2021

Study Start

August 23, 2019

Primary Completion

July 23, 2024

Study Completion (Estimated)

July 23, 2029

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations

NL(1)