Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study (STEREO-MI)
2026년 7월 6일 업데이트: University of Edinburgh
Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein.
A new version of this test, called Troponin T high-sensitivity Gen 6, has recently been developed and approved for use. It is designed to be more accurate and reliable, detecting smaller changes in troponin levels and being less affected by technical interference. The investigators believe this improved test will allow doctors to diagnose heart attacks more quickly and decide sooner who needs to stay in hospital and who can safely go home. This could help reduce overcrowding in Accident and Emergency (A&E) departments, a major challenge for the NHS.
This study will examine whether switching to this new test across a health board shortens the time patients with suspected heart attacks spend in the Emergency Department. The investigators will use information from the DataLoch Heart Disease Registry, which automatically collects anonymised hospital data for patients attending with possible heart attacks. The investigators will compare data from one year before and one year after implementation to see whether average length of stay changes and to confirm that patient safety remains high. This investigators will also measure both the current and new versions of the troponin test in surplus blood samples collected during two six-month periods-one before and one after the new test is introduced. This will allows the investigators to directly compare the two tests reliably.
Patients will not need to do anything extra to take part - the study uses information and samples already collected as part of their usual care.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
19500
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Andrew R Chapman, MD PhD
- 전화번호: +44131 242 6200
- 이메일: a.r.chapman@ed.ac.uk
연구 장소
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-
Midlothian
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Edinburgh, Midlothian, 영국, EH4 2XU
- 모병
- Western General Hospital
-
연락하다:
- Andrew R Chapman, MD PhD
- 전화번호: +44131 242 6200
- 이메일: a.r.chapman@ed.ac.uk
-
수석 연구원:
- Andrew R Chapman, MD PhD
-
Edinburgh, Midlothian, 영국, EH16 4SA
- 모병
- The Royal Infirmary of Edinburgh
-
연락하다:
- Andrew R Chapman, MD PhD
- 전화번호: +44131 242 6200
- 이메일: a.r.chapman@ed.ac.uk
-
수석 연구원:
- Andrew R Chapman, MD PhD
-
-
West Lothian
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Livingston, West Lothian, 영국, EH54 6PP
- 모병
- St. John's Hospital
-
연락하다:
- Andrew R Chapman, MD PhD
- 전화번호: +44131 242 6200
- 이메일: a.r.chapman@ed.ac.uk
-
수석 연구원:
- Andrew R Chapman, MD PhD
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 18 years and over.
- Attending clinician suspects acute coronary syndrome.
- At least one measurement of cardiac troponin using the Gen 5 or Gen 6 hs-cTnT assay.
Exclusion Criteria:
- Insufficient clinical information to perform record linkage.
- Not resident in Scotland.
- Previous enrolment in the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Pre-implementation
Consecutive patients presenting with suspected acute coronary syndrome for 12 months prior to the implementation of the sixth generation hs-cTnT assay will be enrolled into the "pre-implementation" arm, where care is guided by the current, fifth-generation assay
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Elecsys Troponin T Gen 5 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g.
acute myocardial infarction (AMI).
It is the most widely used high-sensitivity troponin assay globally.
다른 이름들:
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실험적: Post-implementation
Consecutive patients presenting with suspected acute coronary syndrome for 12 months after the implementation of the sixth generation hs-cTnT assay will be enrolled into the "post-implementation" arm, where care is guided by the sixth-generation assay
|
Elecsys Troponin T hs Gen 6 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g.
acute myocardial infarction (AMI).
In contrast to the previous generation of the assay (Elecsys Troponin T hs), the Gen 6 assay has been standardised against recombinant human cardiac troponin T, and has been demonstrated to have greater analytical precision and resistance to interference.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Length of stay within the Emergency Department
기간: From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days
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Length of stay within the Emergency Department, defined as the time from arrival until discharge from the Emergency Department or referral for admission to hospital.
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From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Length of hospital stay
기간: From initial presentation until hospital discharge, up to 1 year
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Total length of hospital stay from presentation until discharge from hospital
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From initial presentation until hospital discharge, up to 1 year
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Hospital admission
기간: From initial presentation to the Emergency Department up to 7 days
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Admission to hospital during index presentation
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From initial presentation to the Emergency Department up to 7 days
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Serial cardiac troponin measurements
기간: From initial presentation until hospital discharge, up to 1 year
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Number of serial cardiac troponin measurements during index admission
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From initial presentation until hospital discharge, up to 1 year
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Cardiovascular death at 30 days
기간: From initial presentation until 30 days after initial presentation
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Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)
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From initial presentation until 30 days after initial presentation
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Cardiovascular death at 1 year
기간: From initial presentation until 1 year after initial presentation
|
Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)
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From initial presentation until 1 year after initial presentation
|
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Myocardial infarction after discharge at 30 days
기간: From initial hospital discharge until 30 days following index presentation
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Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)
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From initial hospital discharge until 30 days following index presentation
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Myocardial infarction after discharge at 1 year
기간: From initial hospital discharge until 1 year following index presentation
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Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)
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From initial hospital discharge until 1 year following index presentation
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Reattendance with suspected myocardial infarction at 30 days
기간: From initial hospital discharge until 30 days following initial presentation.
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A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.
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From initial hospital discharge until 30 days following initial presentation.
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Reattendance with suspected myocardial infarction at 1 year
기간: From initial hospital discharge until 1 year following initial presentation.
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A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.
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From initial hospital discharge until 1 year following initial presentation.
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Unscheduled coronary revascularisation at 30 days
기간: From initial hospital discharge until 30 days following initial presentation
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Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
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From initial hospital discharge until 30 days following initial presentation
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Unscheduled coronary revascularisation at 1 year
기간: From initial hospital discharge until 1 year following initial presentation
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Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.
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From initial hospital discharge until 1 year following initial presentation
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Hospitalisation due to heart failure at 30 days
기간: From discharge from the initial hospital attendance until 30 days from initial presentation
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A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.
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From discharge from the initial hospital attendance until 30 days from initial presentation
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Hospitalisation due to heart failure at 1 year
기간: From discharge from the initial hospital attendance until 1 year from initial presentation
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A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.
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From discharge from the initial hospital attendance until 1 year from initial presentation
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Death at 30 days
기간: From initial presentation until 30 days
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Death due to any cause
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From initial presentation until 30 days
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Death at 1 year
기간: From initial presentation until 1 year
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Death due to any cause
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From initial presentation until 1 year
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Myocardial injury
기간: From initial presentation to hospital until 24 hours after presentation.
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Any cardiac troponin measurement above the sex-specific 99th percentile upper reference limit of the relevant assay, during the first 24 hours of the initial presentation to hospital.
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From initial presentation to hospital until 24 hours after presentation.
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Index myocardial infarction
기간: From initial presentation until hospital discharge, up to 1 year
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Myocardial infarction during the index presentation to hospital (ICD10 codes I21 or I22 associated with the episode in the Scottish Morbidity Record, restricted to position 1 or 2
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From initial presentation until hospital discharge, up to 1 year
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Coronary angiography within 30 days
기간: From initial presentation until 30 days later
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Invasive coronary angiography performed within 30 days of the initial presentation to hospital.
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From initial presentation until 30 days later
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Time until initial troponin test
기간: From initial presentation to hospital until 24 hours after presentation.
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Time from the arrival in the Emergency Department until collection of the first high-sensitivity cardiac troponin test.
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From initial presentation to hospital until 24 hours after presentation.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Andrew R Chapman, MD PhD, University of Edinburgh
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
- Boeddinghaus J, Li Z, Bularga A, Taggart C, Wereski R, Chapman AR, Lee KK, Tuck C, Gunn R, Jenks S, McCance K, Pattenden R, Malo J, Thurston AJF, Tew YY, McDermott M, Gray A, Cruden NLM, Anand A, Kimenai DM, Mills NL; TWITCH-ED Investigators. Clinical Decisions and Outcomes After Switching High-Sensitivity Cardiac Troponin Assays in Suspected ACS: An Interrupted Time-Series Study. JAMA Cardiol. 2026 Feb 1;11(2):186-192. doi: 10.1001/jamacardio.2025.4661.
- Thurston AJF, Tew YY, Lopez-Ayala P, Koechlin L, O'Brien R, Lynch S, Cooper JG, Fujisawa T, Bima P, McDermott M, Tuck C, Mizerska M, Highton-Williamson E, McCurrach F, Lowry MTH, Doudesis D, Anand A, Lee KK, Ferry AV, Chapman A, Newby DE, Boeddinghaus J, Mueller C, Gray AJ, Mills NL; POC-ET and APACE Investigators. Early Rule Out of Myocardial Infarction With a Novel High-Sensitivity Cardiac Troponin T Assay. JAMA Cardiol. 2026 Jun 1;11(6):583-592. doi: 10.1001/jamacardio.2026.0477.
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 (실제)
연구 시작
2026년 6월 1일
기본 완료 (추정된)
기본 완료
2028년 5월 1일
연구 완료 (추정된)
연구 완료
2029년 5월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 5월 22일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 4일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 7일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 6일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- AC25189
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The individual data underlying the study can be made available via a Secure Data Environment to approved researchers on application to DataLoch (dataloch@ed.ac.uk)
IPD 공유 기간
From study conclusion for 5 years
IPD 공유 액세스 기준
Access is contingent on a project application to DataLoch that fulfils key governance criteria on independent review.
Further details may be obtained by contacting dataloch@ed.ac.uk
IPD 공유 지원 정보 유형
- 연구_프로토콜
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. .