Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test in Elderly Patients (BOSCH2)
|ClinicalTrials.gov Identifier: NCT01370382|
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : April 17, 2013
|Condition or disease|
|Acute Coronary Syndrome|
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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Official Title:||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|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||December 2011|
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.
- Incidence of acute coronary syndromes without ST-segment elevation during hospitalization. [ Time Frame: 30 days ]
- Accurate diagnosis of myocardial infarction (without knowledge of biomarkers) [ Time Frame: 30 days ]
- Accurate diagnosis of acute heart failure (without knowledge of biomarkers) [ Time Frame: 30 days ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370382
|Nürnberg, Germany, 90419|
|Principal Investigator:||Philipp Bahrmann, MD||Department of Internal Medicine II-2, Chair of Internal Medicine V, Institute for Biomedicine of Ageing, Friedrich-Alexander-University Erlangen-Nürnberg|