Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test in Elderly Patients

NCT01370382 | Completed

• 1 other identifier: BOSCH2
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The planned cohort study shall clarify whether the use of biomarkers leads to improved diagnostic assessment of elderly patients. The study will evaluate the clinical value of biomarkers (highly sensitive Troponin T, Troponin T of the 4th generation) in elderly patients. These biomarkers are analyzed together with the symptoms and other parameters collected at admission. The diagnosis of myocardial infarction could be made earlier and more accurately with the help of biomarkers, in particular the highly sensitive troponin T.

Conditions

Acute Coronary Syndrome

Keywords

geriatrics; troponin; electrocardiography; diagnosis; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Incidence of acute coronary syndromes without ST-segment elevation during hospitalization.

  30 days

Secondary Outcomes (2)

• Accurate diagnosis of myocardial infarction (without knowledge of biomarkers)

  30 days

• Accurate diagnosis of acute heart failure (without knowledge of biomarkers)

  30 days

Study Arms (1)

Time interval

Patients are divided according to the interval between the onset of chest pain symptoms and presentation at the hospital in an "early"(\<4 hours) and "late"(\> = 4 hours) group.

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 (3)

• Bahrmann P, Heppner HJ, Christ M, Bertsch T, Sieber C. Early detection of non-ST-elevation myocardial infarction in geriatric patients by a new high-sensitive cardiac troponin T assay. Aging Clin Exp Res. 2012 Jun;24(3):290-4. doi: 10.3275/7927. Epub 2011 Sep 26.

  PMID: 21952408 RESULT

• 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 RESULT

• 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 RESULT

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, Institute for Biomedicine of Ageing, Friedrich-Alexander-University 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: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

DE (1)