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

June 25, 2013 updated by: Université de Sherbrooke

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 .

Study Overview

Status

Unknown

Conditions

Detailed 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)

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Quebec
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Recruiting
    - Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
    - Principal Investigator:
      
      Paul Farand, MD MSc
    - Contact:
      
      Paul Farand, MD MSc
      
      Phone Number: 9093 pagette (819) 346-1110
      
      Email: paul.farand@usherbrooke.ca
    - Contact:
      
      Francis Bonenfant, MD
      
      Phone Number: 4987 (819) 346-1110
      
      Email: francis.bonenfant@usherbrooke.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutive patients presenting to the emergency department or being hospitalized for any reason in which we suspect an acute coronary syndrome.

Description

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:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of troponins kinetic in acute coronary syndromes. Time Frame: 72 hours	72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

Principal Investigator: Paul Farand, Md MSc, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria