Assessment of Biomarkers for Diagnosis in Geriatric Patients (BOSCH1)
|ClinicalTrials.gov Identifier: NCT01370395|
Recruitment Status : Unknown
Verified September 2012 by Philipp Bahrmann, University of Erlangen-Nürnberg Medical School.
Recruitment status was: Active, not recruiting
First Posted : June 9, 2011
Last Update Posted : October 1, 2012
|Condition or disease|
|Acute Coronary Syndrome|
All patients admitted to the clinic of acute geriatric medicine during the first 6 months will be enrolled in the study. Included patients will be prospectively studied for cardiovascular events for a period of 24 months.
At admission, patient history, physical examination, prior medications, vital signs including heart rate, blood pressure, body temperature, and all comorbidities will be recorded by a physician. Blood samples will be collected at the time of presentation. Determination of regular laboratory values together with very low circulating troponin T, copeptin, MR-pro-adrenomedullin, ANP and endothelin-1 levels will be measured. An electrocardiogram will be taken in all patients at admission. An echocardiography measuring the function of the heart valves, left ventricular diameters, ejection fraction (LV-EF), and diastolic function will be performed in all patients by a cardiologist in order to differentiate other mechanisms for the release of troponin. According to the result of the echocardiographic exam, the patients will be divided into subgroups with (LV-EF>=55%) and without preserved ejection fraction (LV-EF<55%).
- To investigate the incidence of acute coronary syndromes in geriatric patients by measurement of very low circulating troponin T and copeptin levels.
- To determine cardiovascular events, including cardiovascular death, fatal and nonfatal heart failure, and fatal and nonfatal acute myocardial infarction, of these patients during 24 months.
- To analyze the relationship between very low circulating troponin T and cardiovascular events in these patients.
- To analyze risk factors in geriatric patients with elevated troponin T for cardiovascular events.
- To analyze whether the combined measurement of troponin T and copeptin or other markers improves the sensitivity for identification of acute coronary syndromes in geriatric patients.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Assessment of Biomarkers for Diagnosis in Geriatric Patients With the Symptom of Chest Pain in the Emergency Room|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||December 2013|
Left ventricular function
According to the result of the echocardiographic exam, the patients will be divided into subgroups with (LV-EF>=55%) and without preserved ejection fraction (LV-EF<55%).
- cardiovascular death [ Time Frame: 24 months ]
- fatal and nonfatal acute myocardial infarction [ Time Frame: 24 months ]
- fatal and nonfatal heart failure [ Time Frame: 24 months ]hospitalization for fatal and nonfatal heart failure
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370395
|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-Universität Erlangen-Nürnberg|