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Coronary Artery Bypass Graft (CABG)SCARNCT07316777

Saudi CABG Audit and Registry

An observational study of Coronary Artery Bypass Graft (CABG), run by King Faisal Specialist Hospital & Research Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Bypass Graft (CABG)
What is being tested?
Prospective Clinical Data Collection
How many people
3,000 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 31 Dec 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: 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.

Being tested
Prospective Clinical Data Collection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prospective Clinical Data CollectionOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 30 days post-surgery

  3. 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.

    Measured: From surgery until 30 days post-operation

  4. 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.

    Measured: Perioperative/Periprocedural

Secondary outcomes (13)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. Incidence of 30-day readmission

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

    Measured: Within 30 days post-discharge

  5. 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).

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

  6. 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.

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

  7. 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.

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

  8. Blood product utilization

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

    Measured: Intraoperative through 24 hours post-surgery

  9. One-year survival

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

    Measured: 1 year post-surgery

  10. One-year MACCE

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

    Measured: 1 year post-surgery

  11. Return to work or usual activity

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

    Measured: 1 year post-surgery

  12. 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.

    Measured: Baseline, 6 months, 1 year

  13. 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.

    Measured: Baseline, 6 months, and 1 year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07316777
Sponsor's protocol ID
2251502
Acronym
SCAR
Status last verified
Dec 2025
First submitted
27 Nov 2025
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

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

    PubMed 26123033

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Bypass Graft (CABG), run by King Faisal Specialist Hospital & Research Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of In-hospital mortality (time frame: From date of surgery through hospital discharge, an average of 7-10 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07316777, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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