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

This study is not yet open for participant recruitment.
Verified September 2012 by Universitaire de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01698021
First received: September 28, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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 .


Condition
Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Universitaire de Sherbrooke:

Estimated Enrollment: 500
Study Start Date: November 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698021

Contacts
Contact: Paul Farand, MD MSc (819) 346-1110 ext 9093 pagette paul.farand@usherbrooke.ca
Contact: Francis Bonenfant, resident (819) 346-1110 ext 4987 pagette francis.bonenfant@usherbrooke.ca

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Universitaire de Sherbrooke
Investigators
Principal Investigator: Paul Farand, Md MSc Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01698021     History of Changes
Other Study ID Numbers: Projet 12-081
Study First Received: September 28, 2012
Last Updated: September 28, 2012
Health Authority: Canada: Health Canada

Keywords provided by Universitaire de Sherbrooke:
Creatine Kinase, MB form
Troponin
Acute coronary syndrome
myocardial infarction
Unstable angina

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 23, 2013