Assessment of Biomarkers for Diagnosis in Geriatric Patients (BOSCH1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Klinikum Nürnberg
Information provided by (Responsible Party):
Philipp Bahrmann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01370395
First received: June 8, 2011
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

Elderly patients are often admitted to hospital because of chest pain that is atypical for angina pectoris. In case of inconclusive electrocardiograms, determination of troponin is important for the diagnosis of an acute coronary syndrome. A highly sensitive assay for troponin T has recently been developed, permitting measurements of concentrations that are lower by a factor 10 than those measureable with conventional assays. In patients with stable coronary artery disease these concentrations were significantly associated with the incidence of cardiovascular death and heart failure but not with myocardial infarction. Copeptin, a novel biomarker of endogenous stress, may improve the diagnostic performance of troponin for an acute coronary syndrome in elderly patients. Other biomarkers such as MR-pro-adrenomedullin and endothelin-1 could improve both the diagnostic and prognostic assessment of the physician in these patients.


Condition
Acute Coronary Syndrome

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • cardiovascular death [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Serum and plasma blood samples


Estimated Enrollment: 250
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)
Groups/Cohorts
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%).

Detailed Description:

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%).

Objectives:

  1. To investigate the incidence of acute coronary syndromes in geriatric patients by measurement of very low circulating troponin T and copeptin levels.
  2. 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.
  3. To analyze the relationship between very low circulating troponin T and cardiovascular events in these patients.
  4. To analyze risk factors in geriatric patients with elevated troponin T for cardiovascular events.
  5. 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.
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria:

  • Age 70 or older
  • Signed informed consent

Exclusion Criteria:

  • Hospitalization for unstable angina pectoris within the last 2 month
  • ST-segment elevation myocardial infarction
  • Heart valve defects with need for surgical intervention
  • Coronary bypass surgery or percutaneous transluminal angioplasty within the last 3 months
  • Planned elective coronary revascularization
  • Serum creatinine> 2.0 mg / dl (177 µmol / liter)
  • Serum potassium> 5.5 mmol / l
  • Limited survival probability within the next 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370395

Locations
Germany
Klinikum
Nürnberg, Germany, 90419
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Klinikum Nürnberg
Investigators
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
  More Information

No publications provided by University of Erlangen-Nürnberg Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philipp Bahrmann, MD, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01370395     History of Changes
Other Study ID Numbers: BOSCH1
Study First Received: June 8, 2011
Last Updated: September 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:
geriatrics
troponin
electrocardiography
diagnosis
myocardial infarction

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014