Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome (QUANTUM)
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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 |
| 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) |
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 |
All consecutive patients presenting to the emergency department or being hospitalized for any reason in which we suspect an acute coronary syndrome.
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| 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 |
| Canada, Quebec | |
| Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| 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