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Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites (ATLAS)

2 november 2026 bijgewerkt door: Union Health System

ATLAS is a prospective, observational, multicenter cohort study of how accurately the Universal Cardiac Surgical Risk Score (UCSRS) predicts 30-day outcomes after adult cardiac surgery, compared head-to-head with two established models, STS-PROM and EuroSCORE II. Consecutive adult patients undergoing cardiac surgery are enrolled at each participating center over 12 months. All three scores are recorded for each patient. No score is returned to the treating team or influences clinical care. Discrimination and calibration of each score are assessed against 30-day major adverse cardiac and cerebrovascular events (MACCE). The model under evaluation, UCSRS version 3.2, was specified and calibrated against published registry mortality using simulated patients before enrollment. No simulated patient has an outcome, so no performance claim is made before this study.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

DATA AND ANALYSIS Each site records the clinical variables from which the scores are computed, the site's own STS-PROM and EuroSCORE II values (comparators only; they never enter the UCSRS score), the Frailty Test components, and the 30-day outcome components. Sites compute no derived quantities; every derived value is computed centrally by the same code.

Data are de-identified at the site. A site either sends a de-identified patient-level dataset to the coordinating center or runs the identical standardized analysis locally and shares only summary results (c-statistic, observed/expected ratio, calibration slope and intercept), which are combined by summary-level meta-analysis. Discrimination uses the c-statistic with the DeLong test; calibration uses calibration plots, the observed/expected ratio, and calibration slope and intercept.

MODEL UNDER EVALUATION UCSRS version 3.2 (specification 3.2.0) has a single log-odds baseline computed from the patient's own clinical variables, to which it adds a required frailty correction (Frailty Test, 0-6: chair-rise, cognition assessment, hemoglobin, albumin) and optional corrections for liver function (MELD), left ventricular geometry and coronary complexity (SYNTAX), and right-heart catheterization. STS-PROM and EuroSCORE II are calculated independently by each site on the official calculators and are used only as comparators.

VERSION HISTORY Version 1.0 was published (J Cardiothorac Surg 2026; DOI 10.1186/s13019-026-04433-x), with a baseline blending STS-PROM and EuroSCORE II. Version 2.0 (27 August 2026) removed STS-PROM from the baseline. Version 2.1 (28 August 2026) rebuilt the baseline in log-odds. Version 3.0 replaced the blend with a single logistic baseline from which EuroSCORE II was removed entirely. Version 3.1 (20 September 2026) reset the calibration constant. Version 3.2 (24 October 2026) counted aortic disease once, lowered the MELD slopes, applied the frailty ladder to the odds, added CABG + AVR + MVR as an operation, and re-solved the calibration constant. Each change is recorded in a dated specification of record. The protocol registered here is ATLAS Study Protocol version 4.3 (24 October 2026), which describes UCSRS version 3.2.

SIMULATION AND CALIBRATION The calibration constants were set before enrollment against published mortality from thirteen surgical registries. For each registry, a synthetic cohort was tuned until its mean EuroSCORE II matched that registry's published observed mortality divided by its published EuroSCORE II observed/expected ratio; this is the only point at which real-world information enters. Runs scored millions of synthetic patients: about 11 million exploratory simulations in version 2.1 (which set no constant); 30,000,000-patient runs across the 13 registry-anchored cohorts in versions 3.0 and 3.1; and, in version 3.2, a 325,000-patient solve, a 520,000-patient hold-out, a 29,999,996-patient locking run and two 2,600,000-patient hold-outs. At the version 3.2 constant the median observed/expected ratio across the 13 registries was 1.0011 in the locking run, with hold-outs of 0.9968 and 0.9936. A separate 1,000,000-patient high-risk validation lowered mean predicted risk from 52.3% (version 3.1) to 20.8% (version 3.2) and the share of patients at the 70% score cap from 40.1% to 0.003%.

STRUCTURAL ENUMERATION On 15 September 2026 a complete factorial enumeration of 318,162,816 input combinations (cells, not patients) was run on a development version of the scoring engine, with a provisional intercept and no calibration shift. It covered elective first-time and redo operations and all eleven procedure codes on a deliberately adverse grid (MELD of 10 or more, hemoglobin 13 g/dL or less, albumin 4.0 g/dL or less). It was used to examine structure only: relative behavior, ordering, dynamic range and saturation at the score cap. Its absolute values are uncalibrated and are not risk estimates. In this grid EuroSCORE II, which carries a single flag for previous cardiac surgery and a single flag for thoracic aortic disease, separated a second redo sternotomy from a first redo by 0.02 percentage points and separated aortic root and arch operations from ascending replacement by 0.18 points; the UCSRS engine distinguished these operations. The results are recorded in a dated results document.

LIMITS OF THE SIMULATIONS No simulated patient has an outcome, and no outcome model was used at any stage. Discrimination therefore cannot be assessed in simulation, and the calibration results show internal consistency, not superiority over STS-PROM or EuroSCORE II. No performance claim accompanies the current specification. The version 3.2 constants were set by the investigator before first enrollment, as a documented exception to an earlier commitment; they are not moved again before 5,000 patients are enrolled.

The coordinating investigator developed UCSRS. This is declared in all study documents and publications, and negative results will be published.

Studietype

Observationeel

Inschrijving (Geschat)

5000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Atiq Rehman, MD
  • Telefoonnummer: (609)304-8397
  • E-mail: atiqmd@aol.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Consecutive adult patients undergoing cardiac surgery at each participating center, enrolled over a 12-month period

Beschrijving

Inclusion Criteria:

  • Age 18 years or older
  • Undergoing cardiac surgery at a participating institution during its enrollment period (isolated CABG, isolated valve, combined CABG and valve, multiple valve, aortic surgery, redo sternotomy, or other adult cardiac surgical procedures, on- or off-pump)
  • Enrolled consecutively, without selection

Exclusion Criteria:

  • Age under 18 years
  • Congenital heart surgery performed under a pediatric program
  • Heart transplantation or ventricular assist device implantation as the primary procedure
  • Cases in which the comparator scores cannot be computed from available pre-operative data

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Adult cardiac surgery patients

Consecutive patients 18 years or older undergoing cardiac surgery at a participating site. Risk scores are calculated for research only and do not change care

Calculation of UCSRS, STS-PROM and EuroSCORE II risk scores from pre-operative data, for assessment of discrimination and calibration against observed 30-day outcomes. UCSRS coefficients are fixed and version-locked. No effect on clinical care

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
30 day MACCE
Tijdsspanne: 30 days after surgery

Occurrence within 30 days after surgery of any component of a composite of all-cause mortality, permanent stroke, renal failure (per the current STS Adult Cardiac Surgery Database definition) and prolonged ventilation (more than 24 hours). STS standard definitions are applied at all sites. Used to assess discrimination and calibration of UCSRS, STS-PROM and EuroSCORE II.

30 days after surgery
30 day all cause mortality
Tijdsspanne: 30 day after surgery

Death from any cause within 30 days of the index procedure, or in-hospital death after day 30 where the patient has remained continuously admitted since the index procedure. Used to assess calibration (observed/expected ratio, calibration slope and intercept) of UCSRS, STS-PROM and EuroSCORE II.

30 day after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reoperation
Tijdsspanne: 30 days after surgery

Reoperation for any cause within 30 days after surgery (STS definition)

30 days after surgery
Number of Participants with Deep Sternal Wound Infection
Tijdsspanne: 30 days after surgery

Deep Sternal wound infection within 30 days of surgery (STS definition)

30 days after surgery
Number of Participants with Major Bleeding
Tijdsspanne: 30 days after surgery

Major bleeding within 30 days of surgery (STS definition)

30 days after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: Atiq Rehman, MD, Union Health System

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • Universal cardiac surgical risk score (UCSRS v1.0) a unified physiology-informed risk architecture for operative mortality prediction across all adult cardiac surgical procedures: algorithm design and prospective validation protocol; J Cardiothoracic Surgery, Accepted in July 2026; (In-Press) DOI: 10.1186/s13019-026-04433

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

27 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

5 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • UCSRS ATLAS
  • 20263741 (Andere identificatie: WCG Clinical Services)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared. The coordinating center holds pooled data made up of de-identified patient-level data from sites that choose to share it and summary results from sites that analyze locally. These are held under site data use agreements and local ethics approvals that do not permit onward sharing. Aggregate results will be published

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .