Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CAAE 04482712.3.0000.5333 | Other Identifier | Plataforma Brasil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto de Cardiologia de Santa Catarina | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce the inflammatory profile in acute ischemic disease and reduce the area of ischemia. Methotrexate is a drug that has shown promise in ischemic disease in animal studies.
Atherosclerosis and ischemic disease have clear association with inflammation. There is an anti-inflammatory action of methotrexate by increasing adenosine. Experimental studies demonstrate reduction of infarct induced in animals treated with methotrexate. We expect a reduction in the area under the curve of creatine kinase (CK), creatine kinase MB fraction (CK-MB) and Troponin I high sensitive, decreased levels of B-type natriuretic peptide (BNP) and improvement in left ventricular ejection fraction.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Experimental | Established treatment associated with methotrexate |
|
| Placebo (Riboflavin) | Placebo Comparator | Established treatment associated with placebo (riboflavin sodium fosfate 0.1%). We use riboflavin in placebo group to remain the double-blind fashion: methotrexate has a yellow color and riboflavin in that concentration has the same color. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | The treatment group will receive a bolus dose of 0.05 mg/kg of methotrexate before primary angioplasty followed by 0.05 mg/kg per hour for 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve of creatine kinase | The primary end point was the reduction of the size of the infarct as assessed by the area under the curve (AUC) (expressed in arbitrary units) for creatine kinase (CK) during 72 hours after the infarct | During 72 hours after the infarct |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for creatine kinase MB fraction and troponin I high sensitive | The primary end point was the reduction of the size of the infarct as assessed by the area under the curve (AUC) (expressed in arbitrary units) for creatine kinase MB fraction(CK-MB) and Troponin I high sensitive during 72 hours after the infarct | During 72 hours after the infarct |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel M. Moreira, MSc. | Contact | 554884175590 | danielmedeirosmoreira@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel M. Moreira, MD. MSc. | Instituto de Cardiologia do Rio Grande do Sul | Study Chair |
| Daniel M. Moreira, MD. MSc | Instituto de Cardiologia do Rio Grande do Sul | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia | Porto Alegre | Rio Grande do Sul | 90620001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28325070 | Derived | Moreira DM, Lueneberg ME, da Silva RL, Fattah T, Gottschall CAM. MethotrexaTE THerapy in ST-Segment Elevation MYocardial InfarctionS: A Randomized Double-Blind, Placebo-Controlled Trial (TETHYS Trial). J Cardiovasc Pharmacol Ther. 2017 Nov;22(6):538-545. doi: 10.1177/1074248417699884. Epub 2017 Mar 22. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Riboflavin | Drug | We use riboflavin in placebo group to remain the double-blind fashion: methotrexate has a yellow color and riboflavin in that concentration has the same color. |
|
| Compare the peaks of CK, CK-MB and troponin I ultra-sensitive | Compare the peaks of CK, CK-MB and troponin I ultra-sensitive | During 72 hours after the infarct |
| Compare the levels of high-sensitivity C-reactive protein at admission, after 72 hours and after 3 months | Compare the levels of high-sensitivity C-reactive at admission, after 72 hours and after 3 months | After 72 hours and after 3 months |
| Compare the levels of erythrocyte sedimentation rate on admission and after 72 hours | Compare the levels of erythrocyte sedimentation rate on admission and after 72 hours | On admission and after 72 hours |
| Compare B-type natriuretic peptide (BNP) levels on admission, after 72 hours and after 3 months | Compare B-type natriuretic peptide (BNP) levels on admission, after 72 hours and after 3 months | On admission, after 72 hours and after 3 months |
| Compare the "TIMI frame count" of the culprit artery | Compare the "TIMI frame count" of the culprit artery | On admission |
| Compare the Killip score on admission and after 72 hours | Compare the Killip score on admission and after 72 hours; | On admission and after 72 hours |
| Assess ventricular ejection fraction with transthoracic echocardiography during the first 72 hours after 3 months | Assess ventricular ejection fraction with transthoracic echocardiography during the first 72 hours after 3 months | During the first 72 hours after 3 months |
| Assess mortality at 3 months | Assess mortality at 3 months; | At 3 months; |
| Evaluate reinfarction in 3 months | Evaluate reinfarction in 3 months | In 3 months |
| Rate side effects | Evaluation in 72 hours the changes in the levels of hematocrit, hemoglobin, leukocytes and platelets, changes in the levels of serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase and prothrombin Time; changes in the levels of plasma creatinine, gastrointestinal effects (oral ulcers, diarrhea, nausea and vomiting), skin changes (rash, pruritus, and alopecia) and pulmonary effects (pneumonitis and pneumonia). | In 72 hours |
| Daniel M. Moreira, MD. MSc. |
| Instituto de Cardiologia do Rio Grande do Sul |
| Principal Investigator |
| Carlos AM Gottschall, MD MSc PhD | Instituto de Cardiologia do Rio Grande do Sul | Study Director |
| Maria E. Lueneberg, MD. | Instituto de Cardiologia de Santa Catarina | Study Director |
| Roberto L. da Silva, MD. | Instituto de Cardiologia de Santa Catarina | Study Director |
| Tammuz Fattah, MD. | Instituto de Cardiologia de Santa Catarina | Study Director |
| Instituto de Cardiologia de Santa Catarina | São José | Santa Catarina | 88103901 | Brazil |
|
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005415 | Flavins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |