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Saudi CABG Audit and Registry

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07316777
Acronym
SCAR
Enrollment
3000
Registered
2026-01-05
Start date
2026-01-01
Completion date
2027-12-31
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Graft (CABG)

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.

Interventions

OTHERProspective 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 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.

Sponsors

King Faisal Specialist Hospital & Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of In-hospital mortalityFrom date of surgery through hospital discharge, an average of 7-10 days.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.
Incidence of 30-day major adverse cardiac and cerebrovascular events (MACCE)30 days post-surgeryComposite 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.
Incidence of Deep sternal wound infection (DSWI)From surgery until 30 days post-operationIncidence 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.
Unplanned reoperation for bleeding, tamponade, or graft-related technical failurePerioperative/PeriproceduralIncidence 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.

Secondary

MeasureTime frameDescription
Number of Participants with Post Operative Acute kidney injury (AKI)From date of surgery through hospital discharge, an average of 7-10 days.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).
Incidence of New renal replacement therapy InitiationFrom date of surgery through hospital discharge, an average of 7-10 days.Initiation of postoperative renal replacement therapy (intermittent dialysis or continuous renal replacement therapy) that was not required preoperatively.
Number of Participants with post operative New-onset atrial fibrillationFrom date of surgery through hospital discharge, an average of 7-10 days.Incidence of atrial fibrillation requiring medical or procedural intervention following CABG, documented on electrocardiography or continuous telemetry.
Blood product utilizationIntraoperative through 24 hours post-surgeryNumber and type of transfused blood products (red blood cells, plasma, platelets, cryoprecipitate) during and after CABG surgery.
Intensive care unit (ICU) length of stayFrom the date of surgery through initial ICU discharge (average of 3-5 days).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.
One-year MACCE1 year post-surgeryComposite of all-cause mortality, stroke, myocardial infarction, and repeat revascularization occurring within 1 year after CABG.
Return to work or usual activity1 year post-surgeryProportion of patients who resume employment or routine daily activity within 1 year after CABG.
EuroQol-5 Dimension (EQ-5D)Baseline, 6 months, 1 yearChange 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.
Short Form Health Survey (SF-36)Baseline, 6 months, and 1 year post-surgeryChange 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.
One-year survival1 year post-surgeryAll-cause survival at 1 year following CABG surgery, assessed through clinical follow-up and health records.
Total hospital length of stayFrom the date of surgery through hospital discharge (average of 7-10 days).Duration of hospitalization from the day of surgery until discharge, measured in days. Includes all in-hospital recovery time after CABG.
Duration of mechanical ventilationFrom completion of surgery through extubation, an average of 12-24 hoursTotal time on postoperative mechanical ventilation following CABG surgery, measured in hours. Includes any episodes of re-intubation requiring ventilatory support.
Incidence of 30-day readmissionWithin 30 days post-dischargeIncidence of all-cause hospital readmission occurring within 30 days of discharge after CABG surgery.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026