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NCT01698021 Clinical Trial

Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome

Myocardial Infarction Clinical Trial

— QUANTUM  

Official title:
Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01698021
Other study ID # Projet 12-081
Secondary ID
Status Recruiting
Phase N/A
First received September 28, 2012
Last updated June 25, 2013
Start date June 2013
Est. completion date November 2013

Study information
Verified date September 2012
Source Université de Sherbrooke
Contact Paul Farand, MD MSc
Phone (819) 346-1110
Email paul.farand@usherbrooke.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

The new assay of troponins T (highly sensitive troponins) detects concentrations much lower than before. Few data are currently available on their kinetics during acute coronary syndrome, especially in regard to the correlation with CK MB. The aim of the present study is to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to correlate it with the concentration of CK MB, and possibly to evaluate their prognostic value with respect to infarct size .

Description:

Patients who meet the inclusion criteria will have a highly sensitive troponins and CKMB assays q 8hr for the first day, and q 12h for the next 2 days. If clinically not indicated, the blood sample can be cancelled at any time, as in the case of a patient with an initial suspicion of acute coronary syndrome in which the final diagnosis is something else. Only patients with a definitive myocardial infarction will be analyzed.

Subgroup analyses includes ST-elevation MI, Non ST-elevation MI, revascularization vs no revascularization, procedural myocardial infarction.

Another analysis conducted is the correlation between the values of troponin and infarct size by echocardiography (in patients who have an echocardiography 2-7 days post AND 2-6 months post myocardial infarction)

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >= 18 years-old

- Clinical suspicion of an acute coronary syndrome; (will be analyzed only patients with aposteriori definitive diagnosis of unstable angina or myocardial infarction)

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie Sherbrooke Quebec

Sponsors (1)
Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of troponins kinetic in acute coronary syndromes. 72 hours No
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