Assessment of Biomarkers for Diagnosis in Geriatric Patients

NCT01370395 | Unknown

• 1 other identifier: BOSCH1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Keywords

geriatrics; troponin; electrocardiography; diagnosis; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• cardiovascular death

  24 months

Secondary Outcomes (2)

• fatal and nonfatal acute myocardial infarction

  24 months

• fatal and nonfatal heart failure

  24 months

Study Arms (1)

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%).

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• Age 70 or older
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Klinikum Nürnberg: collaborator

Study Sites (1)

Klinikum

Nuremberg, 90419, Germany

Location

Related Publications (2)

• Bahrmann P, Christ M, Bahrmann A, Rittger H, Heppner HJ, Achenbach S, Bertsch T, Sieber CC. A 3-hour diagnostic algorithm for non-ST-elevation myocardial infarction using high-sensitivity cardiac troponin T in unselected older patients presenting to the emergency department. J Am Med Dir Assoc. 2013 Jun;14(6):409-16. doi: 10.1016/j.jamda.2012.12.005. Epub 2013 Jan 30.

  PMID: 23375478 DERIVED

• Bahrmann P, Bahrmann A, Breithardt OA, Daniel WG, Christ M, Sieber CC, Bertsch T. Additional diagnostic and prognostic value of copeptin ultra-sensitive for diagnosis of non-ST-elevation myocardial infarction in older patients presenting to the emergency department. Clin Chem Lab Med. 2013 Jun;51(6):1307-19. doi: 10.1515/cclm-2012-0401.

  PMID: 23314553 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma blood samples

MeSH Terms

Conditions

Acute Coronary Syndrome; Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis

Study Officials

• Philipp Bahrmann, MD

  Department of Internal Medicine II-2, Chair of Internal Medicine V, Institute for Biomedicine of Ageing, Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 9, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

DE (1)