- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01370382
Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test in Elderly Patients (BOSCH2)
Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test of the 4th Generation for the Early Identification of Myocardial Necrosis in Elderly Patients With Acute Coronary Syndromes Without ST-segment Elevation
연구 개요
상태
정황
상세 설명
All consecutive patients with acute symptoms and an age over 70 years will be recruited for the study during 6 months. Medical history, physical examination, vital signs including heart rate, blood pressure, body temperature, and any concomitant diseases are raised on admission in the Emergency Department. Blood samples are taken for determination of routine laboratory. Highly sensitive troponin T is determined as part of the routine. Troponin T is measured from the same blood sample with a conventional test of the 4th generation. A second blood sample is taken as part of routine 4-6 hours after the onset of symptoms to confirm or rule out any acute coronary syndrome. Patients are divided according to the interval between the onset of symptoms and presentation at the hospital in an "early"(<4 hours) and "late"(> = 4 hours) group.
The Barthel Index as a geriatric assessment is raised. An electrocardiogram is written in all patients at recording and evaluated. An echocardiographic examination is performed in all patients for measurement of heart valve function, left ventricular diameter, ejection fraction (LVEF) and diastolic function to differentiate into other mechanisms for the release of troponin. According to the results of the echocardiographic examination, patients are divided into sub-groups (LV-EF> = 55%) and without preserved ejection fraction (LVEF <55%). The recording physician estimates after receiving the results of the investigations and routine laboratory whether a myocardial infarction or heart failure is present. He subsequently makes the decision about further treatment. The medical records will be evaluated after completion of the stay in hospital by two experienced cardiologists, whether a heart attack, heart failure or other disease was present. High sensitivity Troponin T and Troponin T of the 4th generation are compared for the early and correct diagnosis of acute coronary syndrome.
Objectives:
- Incidence of acute coronary syndromes without ST-segment elevation in elderly patients by using the highly sensitive biomarker troponin T,
- Comparison with the incidence of acute coronary syndromes without ST-segment elevation in the same group by the use of troponin T of the 4th generation
- Survey on differential diagnoses such as heart failure or other cardiac diseases.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Nürnberg, 독일, 90419
- Klinikum
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 70 or older
- Signed informed consent
Exclusion Criteria:
- Hospitalization for unstable angina pectoris within the last 2 month
- ST-segment elevation myocardial infarction
- Heart valve defects with need for surgical intervention
- Coronary bypass surgery or percutaneous transluminal angioplasty within the last 3 months
- Planned elective coronary revascularization
- Serum creatinine> 2.0 mg / dl (177 µmol / liter)
- Serum potassium> 5.5 mmol / l Limited survival probability within the next 3 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Time interval
Patients are divided according to the interval between the onset of chest pain symptoms and presentation at the hospital in an "early"(<4 hours) and "late"(> = 4 hours) group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Incidence of acute coronary syndromes without ST-segment elevation during hospitalization.
기간: 30 days
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30 days
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Accurate diagnosis of myocardial infarction (without knowledge of biomarkers)
기간: 30 days
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30 days
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Accurate diagnosis of acute heart failure (without knowledge of biomarkers)
기간: 30 days
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30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Philipp Bahrmann, MD, Department of Internal Medicine II-2, Institute for Biomedicine of Ageing, Friedrich-Alexander-University Erlangen-Nürnberg
간행물 및 유용한 링크
일반 간행물
- Bahrmann P, Heppner HJ, Christ M, Bertsch T, Sieber C. Early detection of non-ST-elevation myocardial infarction in geriatric patients by a new high-sensitive cardiac troponin T assay. Aging Clin Exp Res. 2012 Jun;24(3):290-4. doi: 10.3275/7927. Epub 2011 Sep 26.
- Bahrmann P, Christ M, Bahrmann A, Rittger H, Heppner HJ, Achenbach S, Bertsch T, Sieber CC. A 3-hour diagnostic algorithm for non-ST-elevation myocardial infarction using high-sensitivity cardiac troponin T in unselected older patients presenting to the emergency department. J Am Med Dir Assoc. 2013 Jun;14(6):409-16. doi: 10.1016/j.jamda.2012.12.005. Epub 2013 Jan 30.
- Bahrmann P, Bahrmann A, Breithardt OA, Daniel WG, Christ M, Sieber CC, Bertsch T. Additional diagnostic and prognostic value of copeptin ultra-sensitive for diagnosis of non-ST-elevation myocardial infarction in older patients presenting to the emergency department. Clin Chem Lab Med. 2013 Jun;51(6):1307-19. doi: 10.1515/cclm-2012-0401.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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