VIADUCT: Prior CABG Patients Evaluated for Saphenous VeIn Graft DysfUnction and Progression of Coronary arTery Disease

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Recruiting

CT.gov ID

NCT04772768

Collaborator

(none)

500

Enrollment

Location

119

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multi-center, observational cohort study. Patients with recurrent angina symptoms and a cardiac history of coronary artery bypass grafting (CABG) with one or more saphenous vein grafts (SVG) will be eligible for inclusion in this registry. Study objective: to investigate the clinical outcomes in patients with prior CABG evaluated for SVG dysfunction and progression of coronary artery disease (CAD). Follow-up will be collected through electronic medical patient records and standardized telephonic assessment at 1, 3 and 5 years follow-up.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Angina After Coronary Artery Bypass Graft Graft Failure Coronary Artery Disease Progression

Detailed Description

All patients with a history of CABG with one or more venous bypass grafts and recurrent angina symptoms who are referred to the Amsterdam University Medical Centers will be screened for potential inclusion in the registry. Patients will be eligible for inclusion in the registry after consideration of in- and exclusion criteria. Subsequently patients will be approached for study participation. Patients can freely withdraw informed consent to participate in the study at any time.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 23, 2019

Anticipated Primary Completion Date :

Jul 23, 2024

Anticipated Study Completion Date :

Jul 23, 2029

Outcome Measures

Primary Outcome Measures

Major adverse cardiovascular events (MACE) [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)
Saphenous vein graft failure [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 Outcome Measures

Major Adverse Cardiac Events [3 and 5 years follow-up]
Components of MACE (all-cause mortality, non-fatal myocardial infarction, or clinically driven repeat revascularization)
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 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)
Procedural success and mortality in patients who underwent percutaneous coronary intervention of the bypassed native coronary artery [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)
Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale [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.
Quality of life assessed by Rose dyspnea scale questionnaire (RDS) [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.
Composite score of quality of life [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