Saudi CABG Audit and Registry (SCAR)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Bypass Graft (CABG)
• Intervention / Treatment: Other: Prospective Clinical Data Collection

• Study Type: Observational
• Enrollment (Estimated): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care unit (ICU) length of stay	Duration of postoperative stay in the intensive care unit following CABG surgery, measured in hours or days. Includes all ICU readmissions during the index hospitalization.	From the date of surgery through initial ICU discharge (average of 3-5 days).
Total hospital length of stay	Duration of hospitalization from the day of surgery until discharge, measured in days. Includes all in-hospital recovery time after CABG.	From the date of surgery through hospital discharge (average of 7-10 days).
Duration of mechanical ventilation	Total time on postoperative mechanical ventilation following CABG surgery, measured in hours. Includes any episodes of re-intubation requiring ventilatory support.	From completion of surgery through extubation, an average of 12-24 hours
Incidence of 30-day readmission	Incidence of all-cause hospital readmission occurring within 30 days of discharge after CABG surgery.	Within 30 days post-discharge
Number of Participants with Post Operative Acute kidney injury (AKI)	Occurrence of acute kidney injury following CABG, defined according to KDIGO criteria (increase in serum creatinine ≥0.3 mg/dL within 48 hours, ≥1.5× baseline within 7 days, or urine output <0.5 mL/kg/h for 6 hours).	From date of surgery through hospital discharge, an average of 7-10 days.
Incidence of New renal replacement therapy Initiation	Initiation of postoperative renal replacement therapy (intermittent dialysis or continuous renal replacement therapy) that was not required preoperatively.	From date of surgery through hospital discharge, an average of 7-10 days.
Number of Participants with post operative New-onset atrial fibrillation	Incidence of atrial fibrillation requiring medical or procedural intervention following CABG, documented on electrocardiography or continuous telemetry.	From date of surgery through hospital discharge, an average of 7-10 days.
Blood product utilization	Number and type of transfused blood products (red blood cells, plasma, platelets, cryoprecipitate) during and after CABG surgery.	Intraoperative through 24 hours post-surgery
One-year survival	All-cause survival at 1 year following CABG surgery, assessed through clinical follow-up and health records.	1 year post-surgery
One-year MACCE	Composite of all-cause mortality, stroke, myocardial infarction, and repeat revascularization occurring within 1 year after CABG.	1 year post-surgery
Return to work or usual activity	Proportion of patients who resume employment or routine daily activity within 1 year after CABG.	1 year post-surgery
EuroQol-5 Dimension (EQ-5D)	Change in health-related quality of life after coronary artery bypass grafting (CABG), measured using the EuroQol 5-Dimension (EQ-5D) questionnaire. The EQ-5D index score ranges from 0 to 1, where 0 represents the worst possible health state and 1 represents the best possible health state. Higher scores indicate better health-related quality of life. The EQ-5D will be administered at baseline, 6 months, and 1 year to evaluate changes over time.	Baseline, 6 months, 1 year
Short Form Health Survey (SF-36)	Change in health-related quality of life after coronary artery bypass grafting (CABG), measured using the 36-Item Short Form Health Survey (SF-36). Each of the eight domains is scored from 0 to 100, where 0 represents the worst health status and 100 represents the best health status. Higher scores indicate better functional and mental health outcomes. The SF-36 will be administered at baseline, 6 months, and 1 year to assess longitudinal recovery.	Baseline, 6 months, and 1 year post-surgery

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2251502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No