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Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test in Elderly Patients (BOSCH2)

This study has been completed.
Sponsor:
Collaborator:
Klinikum Nürnberg
Information provided by (Responsible Party):
Philipp Bahrmann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01370382
First received: June 8, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test of the 4th Generation for the Early Identification of Myocardial Necrosis in Elderly Patients With Acute Coronary Syndromes Without ST-segment Elevation

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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

Primary Outcome Measures:
  • Incidence of acute coronary syndromes without ST-segment elevation during hospitalization. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accurate diagnosis of myocardial infarction (without knowledge of biomarkers) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Accurate diagnosis of acute heart failure (without knowledge of biomarkers) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and plasma blood samples


Enrollment: 180
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

All consecutive patients with acute symptoms and an age over 70 years will be recruited for the study during 6 months. Medical history, physical examination, vital signs including heart rate, blood pressure, body temperature, and any concomitant diseases are raised on admission in the Emergency Department. Blood samples are taken for determination of routine laboratory. Highly sensitive troponin T is determined as part of the routine. Troponin T is measured from the same blood sample with a conventional test of the 4th generation. A second blood sample is taken as part of routine 4-6 hours after the onset of symptoms to confirm or rule out any acute coronary syndrome. Patients are divided according to the interval between the onset of symptoms and presentation at the hospital in an "early"(<4 hours) and "late"(> = 4 hours) group.

The Barthel Index as a geriatric assessment is raised. An electrocardiogram is written in all patients at recording and evaluated. An echocardiographic examination is performed in all patients for measurement of heart valve function, left ventricular diameter, ejection fraction (LVEF) and diastolic function to differentiate into other mechanisms for the release of troponin. According to the results of the echocardiographic examination, patients are divided into sub-groups (LV-EF> = 55%) and without preserved ejection fraction (LVEF <55%). The recording physician estimates after receiving the results of the investigations and routine laboratory whether a myocardial infarction or heart failure is present. He subsequently makes the decision about further treatment. The medical records will be evaluated after completion of the stay in hospital by two experienced cardiologists, whether a heart attack, heart failure or other disease was present. High sensitivity Troponin T and Troponin T of the 4th generation are compared for the early and correct diagnosis of acute coronary syndrome.

Objectives:

  1. Incidence of acute coronary syndromes without ST-segment elevation in elderly patients by using the highly sensitive biomarker troponin T,
  2. Comparison with the incidence of acute coronary syndromes without ST-segment elevation in the same group by the use of troponin T of the 4th generation
  3. Survey on differential diagnoses such as heart failure or other cardiac diseases.
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370382

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-University Erlangen-Nürnberg
  More Information

Publications:

Responsible Party: Philipp Bahrmann, MD, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01370382     History of Changes
Other Study ID Numbers: BOSCH2
Study First Received: June 8, 2011
Last Updated: April 16, 2013
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 June 18, 2013