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

2026년 11월 2일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

5000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Atiq Rehman, MD
  • 전화번호: (609)304-8397
  • 이메일: atiqmd@aol.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
30 day MACCE
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Reoperation
기간: 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
기간: 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
기간: 30 days after surgery

Major bleeding within 30 days of surgery (STS definition)

30 days after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Atiq Rehman, MD, Union Health System

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • 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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 10월 27일

QC 기준을 충족하는 최초 제출

2026년 11월 2일

처음 게시됨 (실제)

2026년 11월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • UCSRS ATLAS
  • 20263741 (기타 식별자: WCG Clinical Services)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .