Assessment of Biomarkers for Diagnosis in Geriatric Patients (BOSCH1)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|