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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAmsterdam UMC, location VUmc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prior coronary artery bypass grafting

One or more saphenous vein grafts

Recurrent angina symptoms

Disqualifiers

<18 years of age

≥ 90 years of age

Cardiogenic shock

Pregnancy

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
3 year follow-up
2

Saphenous vein graft failure

Failure rate and duration of graft patency following prior CABG procedure

Time frame
At the time of referral and during subsequent 3 and 5 years follow-up

Secondary outcomes

1

Major Adverse Cardiac Events

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

Time frame
3 and 5 years follow-up
2

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)

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

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)

Time frame
In hospital and during subsequent 3 and 5 years follow-up
4

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.

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

Other outcomes

Sponsors and contacts

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