Saudi CABG Audit and Registry

NCT07316777 | Not Yet Recruiting

• 1 other identifier: 2251502
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Bypass Graft (CABG)

Outcome Measures

Primary Outcomes (4)

• Incidence of In-hospital mortality

  In-hospital all-cause mortality following coronary artery bypass grafting (CABG), recorded from the time of surgery until discharge. Mortality will be determined using standardized definitions aligned with major cardiac surgery registries such as STS and E-CABG.

  From date of surgery through hospital discharge, an average of 7-10 days.

• Incidence of 30-day major adverse cardiac and cerebrovascular events (MACCE)

  Composite endpoint including 30-day all-cause mortality, stroke, and myocardial infarction after coronary artery bypass grafting (CABG). Event definitions follow standardized criteria used in major cardiac surgery registries, including STS and E-CABG.

  30 days post-surgery

• Incidence of Deep sternal wound infection (DSWI)

  Incidence of deep sternal wound infection following coronary artery bypass grafting (CABG), defined according to Centers for Disease Control and Prevention (CDC) criteria. Includes infections involving muscle, bone, or mediastinum requiring surgical intervention, antibiotics, or drainage.

  From surgery until 30 days post-operation

• Unplanned reoperation for bleeding, tamponade, or graft-related technical failure

  Incidence of unplanned return to the operating room after coronary artery bypass grafting (CABG) due to postoperative bleeding, cardiac tamponade, or graft-related technical failure. Events follow standardized definitions aligned with international cardiac surgery registries.

  Perioperative/Periprocedural

Secondary Outcomes (13)

• Intensive care unit (ICU) length of stay

  From the date of surgery through initial ICU discharge (average of 3-5 days).

• Total hospital length of stay

  From the date of surgery through hospital discharge (average of 7-10 days).

• Duration of mechanical ventilation

  From completion of surgery through extubation, an average of 12-24 hours

• Incidence of 30-day readmission

  Within 30 days post-discharge

• Number of Participants with Post Operative Acute kidney injury (AKI)

  From date of surgery through hospital discharge, an average of 7-10 days.

Interventions

Prospective Clinical Data Collection OTHER

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 technique, complications, readmissions, mortality, and patient-reported quality-of-life measures (EQ-5D and SF-36). No treatments are assigned. The registry functions solely as an observational platform for quality improvement, benchmarking, and long-term outcome monitoring.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) undergoing coronary artery bypass grafting (CABG) at participating cardiac surgery centers in Saudi Arabia. The population includes individuals receiving isolated CABG or CABG with concomitant procedures, performed electively, urgently, or emergently, using on-pump, off-pump, minimally invasive, or robotic approaches.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Clinical Registry and Proposal of Classification of Postoperative Complications. J Cardiothorac Surg. 2015 Jun 30;10:90. doi: 10.1186/s13019-015-0292-z.

  PMID: 26123033 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiac Surgeon

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share