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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Université de Sherbrooke.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01698021
First received: September 28, 2012
Last updated: June 25, 2013
Last verified: September 2012
  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

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Evaluation of troponins kinetic in acute coronary syndromes. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 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   (Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01698021     History of Changes
Other Study ID Numbers: Projet 12-081 
Study First Received: September 28, 2012
Last Updated: June 25, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on December 06, 2016