Saudi CABG Audit and Registry

Официальное название

Protocol for Development and Implementation of the Saudi CABG Audit and Registry: A Prospective National Clinical Registry

Обзор

The Saudi CABG Audit and Registry (SCAR) is a prospective, multicenter national clinical quality registry designed to systematically collect perioperative and long-term outcome data for all patients undergoing coronary artery bypass grafting (CABG) in Saudi Arabia. The registry will begin with a pilot phase in selected tertiary cardiac centers and will progressively expand to national coverage. SCAR captures detailed information on patient demographics, cardiac status, operative techniques, postoperative outcomes, and 1-year follow-up, including patient-reported quality-of-life measures (EQ-5D and SF-36). The aim is to establish a standardized national platform for benchmarking, quality improvement, and real-world evidence generation to support clinical decision-making and health policy development in cardiac surgery. Data are collected prospectively through secure electronic systems, anonymized before central storage, and analyzed using standardized definitions aligned with international registries such as STS and E-CABG.

Вмешательства

• Другое Prospective Clinical Data Collection
  The intervention consists of systematic, prospective collection of standardized clinical, operative, and follow-up data for all adult patients undergoing coronary artery bypass grafting (CABG) at participating centers. Data are recorded across predefined time points, including preoperative assessment, intraoperative details, postoperative in-hospital outcomes, and follow-up at 30 days, 3 months, 6 months, and 1 year. Variables include demographics, comorbidities, cardiac status, operative techni

Первичные конечные точки

• Incidence of In-hospital mortality [Срок оценки: From date of surgery through hospital discharge, an average of 7-10 days.]
• Incidence of 30-day major adverse cardiac and cerebrovascular events (MACCE) [Срок оценки: 30 days post-surgery]
• Incidence of Deep sternal wound infection (DSWI) [Срок оценки: From surgery until 30 days post-operation]
• Unplanned reoperation for bleeding, tamponade, or graft-related technical failure [Срок оценки: Perioperative/Periprocedural]

Вторичные конечные точки (12)

• Intensive care unit (ICU) length of stay [Срок оценки: From the date of surgery through initial ICU discharge (average of 3-5 days).]
• Total hospital length of stay [Срок оценки: From the date of surgery through hospital discharge (average of 7-10 days).]
• Duration of mechanical ventilation [Срок оценки: From completion of surgery through extubation, an average of 12-24 hours]
• Incidence of 30-day readmission [Срок оценки: Within 30 days post-discharge]
• Number of Participants with Post Operative Acute kidney injury (AKI) [Срок оценки: From date of surgery through hospital discharge, an average of 7-10 days.]
• Incidence of New renal replacement therapy Initiation [Срок оценки: From date of surgery through hospital discharge, an average of 7-10 days.]
• Number of Participants with post operative New-onset atrial fibrillation [Срок оценки: From date of surgery through hospital discharge, an average of 7-10 days.]
• Blood product utilization [Срок оценки: Intraoperative through 24 hours post-surgery]
• One-year survival [Срок оценки: 1 year post-surgery]
• One-year MACCE [Срок оценки: 1 year post-surgery]
• Return to work or usual activity [Срок оценки: 1 year post-surgery]
• EuroQol-5 Dimension (EQ-5D) [Срок оценки: Baseline, 6 months, 1 year]

Критерии участия

Критерии включения

• Adult patients aged 18 years or older
• Undergoing isolated CABG
• Undergoing CABG with concomitant procedures (e.g., valve repair or replacement)
• Undergoing on-pump, off-pump, minimally invasive, or robotic CABG
• Procedures performed electively, urgently, or emergently

Критерии исключения

• Redo CABG when the primary operative record is not available
• Patients younger than 18 years

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Alpert JS. Are data from clinical registries of any value? Eur Heart J. 2000 Sep;21(17):1399-401. doi: 10.1053/euhj.2000.2265. No abstract available. PMID 10952831
• Wyse RK, Taylor KM. The development of an international surgical registry: the ECSUR project. The European Cardiac Surgical Registry. Eur J Cardiothorac Surg. 1999 Jul;16(1):2-8. doi: 10.1016/s1010-7940(99)00129-3. PMID 10456394
• Bridgewater B; Society for Cardiothoracic Surgery in GB and Ireland. Cardiac registers: the adult cardiac surgery register. Heart. 2010 Sep;96(18):1441-3. doi: 10.1136/hrt.2010.194019. Epub 2010 May 29. PMID 20511631
• Gitt AK, Bueno H, Danchin N, Fox K, Hochadel M, Kearney P, Maggioni AP, Opolski G, Seabra-Gomes R, Weidinger F. The role of cardiac registries in evidence-based medicine. Eur Heart J. 2010 Mar;31(5):525-9. doi: 10.1093/eurheartj/ehp596. Epub 2010 Jan 20. No abstract available. PMID 20093258
• Biancari F, Ruggieri VG, Perrotti A, Svenarud P, Dalen M, Onorati F, Faggian G, Santarpino G, Maselli D, Dominici C, Nardella S, Musumeci F, Gherli R, Mariscalco G, Masala N, Rubino AS, Mignosa C, De Feo M, Della Corte A, Bancone C, Chocron S, Gatti G, Gherli T, Kinnunen EM, Juvonen T. European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective PMID 26123033

Идентификаторы

NCT: NCT07316777 · 2251502

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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