Меню
Идёт набор NCT04772768

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Recurrent Angina After Coronary Artery Bypass Graft, Graft Failure, Coronary Artery Disease Progression. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Major adverse cardiovascular events (MACE) [Срок оценки: 3 year follow-up]
  • Saphenous vein graft failure [Срок оценки: At the time of referral and during subsequent 3 and 5 years follow-up]
Вторичные конечные точки (6)
  • Major Adverse Cardiac Events [Срок оценки: 3 and 5 years follow-up]
  • Procedural success and mortality in patients who underwent percutaneous coronary intervention of a saphenous vein graft [Срок оценки: 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 [Срок оценки: In hospital and during subsequent 3 and 5 years follow-up]
  • Quality of life assessed by the Canadian Cardiovascular Society (CCS) Grading Scale [Срок оценки: At baseline and during subsequent 3 and 5 years follow-up]
  • Quality of life assessed by Rose dyspnea scale questionnaire (RDS) [Срок оценки: At baseline and during subsequent 3 and 5 years follow-up]
  • Composite score of quality of life [Срок оценки: At baseline and during subsequent 3 and 5 years follow-up]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Amsterdam University Medical Centers, Department of Cardiology — Amsterdam

Публикации

  • 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 39991799

Идентификаторы

NCT: NCT04772768 · Amsterdam UMC 2019.457

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗