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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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Multicenter Nationwide Study for Analysis of the Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction with High Sensitivity Troponin T
Chest pain is the main clinical complaint in emergency room visits and represents the most common symptom of Acute Myocardial Infarction, which is the main cause of death in Brazil and worldwide. Although most patients with chest pain do not have a final diagnosis of AMI, they remain under observation until the diagnosis of AMI is excluded. The most current strategy recommended for rapid AMI exclusion uses high-sensitivity cardiac troponin T at time zero and one hour later. However, some points that have not yet been properly evaluated in previous studies can be evaluated in the current study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort | A minimum of 294 patients will be included in the evaluation of 0 and 1 hour protocol (prospective evaluation). | ||
| Retrospective cohort | A minimum of 1,000 patients will be included in the evaluation of prognostic value of high sensitive cardiac troponin < 5 ng/L(retrospective evaluation). |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of early rule out for myocardial infarction diagnosis | Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of early rule out for myocardial infarction according to type of symptoms | Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours with or without chest pain | 30 days |
| Accuracy of early rule out for myocardial infarction according to chest pain score (TIMI) |
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Inclusion Criteria:
Age ≥ 18 years of age
The patient agrees and signs an informed consent form
One of the following 2 criteria:
Exclusion Criteria:
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Consecutive patients with suspected acute coronary syndrome
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Samaritano Paulista | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37450613 | Derived | de Barros E Silva PGM, Ferreira AA, Malafaia F, Tavares Reis AFM, Sznejder H, Lopes Junior ACA, Agostinho CA, Fonseca LHO, Okitoi DVD, Correa CM, Zincone E, Cury MP, Rosa GAL, Ribeiro HB, Soeiro AM, de Oliveira CAL, Kuusberg GC, Ohe LN, Souza DO, Manfredi AB, Martins AF, Sampaio PPN, Vaz TB, Franco LF, Ferreira CEDS, Lopes RD; IN-HOPE Investigators. Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):755-764. doi: 10.1093/ehjacc/zuad082. |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (TIMI). TIMI score minimum 0 and maximum 7 points (higher scores mean a worse outcome). |
| 30 days |
| Accuracy of early rule out for myocardial infarction according to chest pain score (EDACS) | Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (EDACS). EDACS score minimum -6 and maximum +20 points (higher scores mean a worse outcome). | 30 days |
| Accuracy of early rule out for myocardial infarction according to chest pain score (GRACE) | Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (GRACE). GRACE score minimum 1 and maximum 372 points (higher scores mean a worse outcome). | 30 days |
| Accuracy of early rule out for myocardial infarction according to chest pain score (HEART) | Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (HEART). HEART score minimum 0 and maximum 10 points (higher scores mean a worse outcome). | 30 days |
| Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population. | Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population (retrospective cohort). | 30 days |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |