Assessment of Biomarkers for Diagnosis in Geriatric Patients (BOSCH1)

September 28, 2012 updated by: Philipp Bahrmann, University of Erlangen-Nürnberg Medical School

Assessment of Biomarkers for Diagnosis in Geriatric Patients With the Symptom of Chest Pain in the Emergency Room

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nürnberg, Germany, 90419
        • Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiovascular death
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatal and nonfatal acute myocardial infarction
Time Frame: 24 months
24 months
fatal and nonfatal heart failure
Time Frame: 24 months
hospitalization for fatal and nonfatal heart failure
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOSCH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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