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

Acute Coronary Syndrome Clinical Trial

— BOSCH2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370382
• Other study ID #: BOSCH2
• Status: Completed
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Germany	Klinikum	Nürnberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Klinikum Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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 — View Citation

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 e — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute coronary syndromes without ST-segment elevation during hospitalization.		30 days
Secondary	Accurate diagnosis of myocardial infarction (without knowledge of biomarkers)		30 days
Secondary	Accurate diagnosis of acute heart failure (without knowledge of biomarkers)		30 days