Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test in Elderly Patients (BOSCH2)
| Tracking Information | |||||
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| First Received Date ICMJE | June 8, 2011 | ||||
| Last Updated Date | April 16, 2013 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of acute coronary syndromes without ST-segment elevation during hospitalization. [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01370382 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test in Elderly Patients | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | The planned cohort study shall clarify whether the use of biomarkers leads to improved diagnostic assessment of elderly patients. The study will evaluate the clinical value of biomarkers (highly sensitive Troponin T, Troponin T of the 4th generation) in elderly patients. These biomarkers are analyzed together with the symptoms and other parameters collected at admission. The diagnosis of myocardial infarction could be made earlier and more accurately with the help of biomarkers, in particular the highly sensitive troponin T. |
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| Detailed Description | 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:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum and plasma blood samples |
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| Sampling Method | Probability Sample | ||||
| Study Population | Emergency department of the Klinikum Nürnberg (50,000 attendances per year; the department caters to an urban population of approximately 1 million). |
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| Condition ICMJE | Acute Coronary Syndrome | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 180 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 70 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01370382 | ||||
| Other Study ID Numbers ICMJE | BOSCH2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Philipp Bahrmann, University of Erlangen-Nürnberg Medical School | ||||
| Study Sponsor ICMJE | University of Erlangen-Nürnberg Medical School | ||||
| Collaborators ICMJE | Klinikum Nürnberg | ||||
| Investigators ICMJE |
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| Information Provided By | University of Erlangen-Nürnberg Medical School | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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