Идёт набор NCT04014140

iFR Guided Coronary Artery Bypass Grafting Surgery

— Наблюдательное Ischaemic Heart Disease Coronary Artery Disease Coronary Stenosis

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: В протоколе указаны: Coronary artery bypass grafting surgery (CABG).
Кому может быть актуально: Состояния в реестре: Ischaemic Heart Disease, Coronary Artery Disease, Coronary Stenosis. Базовые параметры: 25 лет — 80 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: Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Long-term Graft Patency Outcomes of LIMA-LAD Post-CABG Surgery Based on iFR Measurements.

Обзор

The expected outcome of better and improved patency of bypass grafts and its direct relation to pre-operative iFR measurements of stenosis as compared to direct visual physiology of stenosis in the coronary angiogram. To establish the correlation between the use of intracoronary physiology and improved graft patency at 12 months for patients undergoing CABG surgery. It is a minimum of 28 and a maximum of 100 patients single-centre proof or concept/ observational study/ pilot study.

Подробное описание

Patients suffering from coronary artery disease undergo coronary artery bypass grafting surgery (CABG) as the standard of care. The selection of which vessels to bypass is usually at the discretion of the surgeon forming an opinion based on the pre-operative angiographic imaging. Intra-coronary physiology (iFR measurements) is more accurate to determine the level of damage to the coronary arteries; however, currently it is not used for CABG pre-assessment, but only for percutaneous intervention also known as stenting as it has been shown to improve outcomes. Although, the use of intracoronary physiology has not been extensively studied or validated in patients undergoing CABG.

Patients with multi-vessel coronary artery disease (CAD) who are planned for surgical revascularization with coronary artery bypass grafting (CABG), will have iFR measurement taken during invasive coronary angiography as part of standard care, they will undergo CABG and will have echocardiography at 3 months and computed tomography coronary angiography (CTCA) at 12 months.

Early graft failure will be assessed by the presentation of any clinical symptoms, major adverse cardiovascular and cerebrovascular events (MACCE) and echocardiography at 3 months. The endpoint will be graft patency as assessed by CT coronary angiography at 12 months.

Anticipated recruitment is 12-24 months. Follow-up with echocardiography at 3 months and a CTCA at 12 months. Quality of Life questionnaire will be completed by the patient at 3 and 12 months during the follow-up appointment.

Patients will continue on optimal medical therapy. Clinic visit and quality of life scale questionnaires will be recorded at 3 and 12 months and echocardiography will be assessed at 3 months. Graft patency at 12 months will be assessed with a CT coronary angiography.

Вмешательства

Процедура Coronary artery bypass grafting surgery (CABG)
Patients with MVCAD will undergo CABG as per standard of care.

Первичные конечные точки

Graft patency [Срок оценки: 12 months]

Вторичные конечные точки (8)

Quality of Life Questionnaire [Срок оценки: 3 and 12 months]
Composite of MACE (MI, Death, stroke, repeat revascularisation) [Срок оценки: 12 months]
Any episode of reintervention [Срок оценки: 12 months]
Incidence of Myocardial infarction [Срок оценки: 12 months]
Incidence of Stroke [Срок оценки: 12 months]
Left ventricular function at 3 months with an echocardiography [Срок оценки: 3 months]
Incidence of Death (all-cause) [Срок оценки: 12 months]
Incident of Death (cardiovascular) [Срок оценки: 12 months]

Критерии участия

Критерии включения

Age of 25 to 80 years of age
Willing to participate and able to understand, read and sign the informed consent form (ICF) before standard of care elective CABG surgery
Undergoing isolated first-time elective CABG surgery
Available pre-operative angiography data with iFR measurements done during the pre-operative angiography