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NCT Number: NCT07316777

Saudi CABG Audit and 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.

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Key information

Conditions

Coronary Artery Bypass Graft (CABG)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of In-hospital mortality

    Time frame: From 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.

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

    Time frame: 30 days post-surgery

    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.

  3. Incidence of Deep sternal wound infection (DSWI)

    Time frame: From surgery until 30 days post-operation

    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.

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

    Time frame: Perioperative/Periprocedural

    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.

Secondary outcomes

  1. Intensive care unit (ICU) length of stay

    Time frame: From 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.

  2. Total hospital length of stay

    Time frame: From 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.

  3. Duration of mechanical ventilation

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

    Total time on postoperative mechanical ventilation following CABG surgery, measured in hours. Includes any episodes of re-intubation requiring ventilatory support.

  4. Incidence of 30-day readmission

    Time frame: Within 30 days post-discharge

    Incidence of all-cause hospital readmission occurring within 30 days of discharge after CABG surgery.

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

    Time frame: 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).

  6. Incidence of New renal replacement therapy Initiation

    Time frame: From 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.

  7. Number of Participants with post operative New-onset atrial fibrillation

    Time frame: From 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.

  8. Blood product utilization

    Time frame: Intraoperative through 24 hours post-surgery

    Number and type of transfused blood products (red blood cells, plasma, platelets, cryoprecipitate) during and after CABG surgery.

  9. One-year survival

    Time frame: 1 year post-surgery

    All-cause survival at 1 year following CABG surgery, assessed through clinical follow-up and health records.

  10. One-year MACCE

    Time frame: 1 year post-surgery

    Composite of all-cause mortality, stroke, myocardial infarction, and repeat revascularization occurring within 1 year after CABG.

  11. Return to work or usual activity

    Time frame: 1 year post-surgery

    Proportion of patients who resume employment or routine daily activity within 1 year after CABG.

  12. EuroQol-5 Dimension (EQ-5D)

    Time frame: Baseline, 6 months, 1 year

    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.

  13. Short Form Health Survey (SF-36)

    Time frame: Baseline, 6 months, and 1 year post-surgery

    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.

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

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

Acronym: SCAR

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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