Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04772768
Status:
RECRUITING
Last Update Posted:
2023-06-02
First Post:
2021-02-22
Brief Title:
Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIADUCT
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None