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

2 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

5000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Atiq Rehman, MD
  • Numer telefonu: (609)304-8397
  • E-mail: atiqmd@aol.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
30 day MACCE
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Reoperation
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 30 days after surgery

Major bleeding within 30 days of surgery (STS definition)

30 days after surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Atiq Rehman, MD, Union Health System

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

  • 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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 stycznia 2027

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

27 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

5 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • UCSRS ATLAS
  • 20263741 (Inny identyfikator: WCG Clinical Services)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .