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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
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
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.
Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, Brazil
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
Time frame: During 72 hours after the infarct
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
Time frame: During 72 hours after the infarct
Compare the peaks of CK, CK-MB and troponin I ultra-sensitive
Compare the peaks of CK, CK-MB and troponin I ultra-sensitive
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: On admission, after 72 hours and after 3 months
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Compare the "TIMI frame count" of the culprit artery
Compare the "TIMI frame count" of the culprit artery
Time frame: On admission
Compare the Killip score on admission and after 72 hours
Compare the Killip score on admission and after 72 hours;
Time frame: 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
Time frame: During the first 72 hours after 3 months
Assess mortality at 3 months
Assess mortality at 3 months;
Time frame: At 3 months;
Evaluate reinfarction in 3 months
Evaluate reinfarction in 3 months
Time frame: 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).
Time frame: In 72 hours