Assessment of Biomarkers for Diagnosis in Geriatric Patients (BOSCH1)
Recruitment status was Active, not recruiting
Acute Coronary Syndrome
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Biomarkers for Diagnosis in Geriatric Patients With the Symptom of Chest Pain in the Emergency Room|
- cardiovascular death [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- fatal and nonfatal acute myocardial infarction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- fatal and nonfatal heart failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]hospitalization for fatal and nonfatal heart failure
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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%).
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|