The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)

The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS: Randomized Double-blind, Placebo-controlled Trial (TETHYS Trial)

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.

Inclusion Criteria:

• Age over 18 years;
• Chest pain suggestive of acute myocardial infarction initiated within 12 hours;
• Electrocardiogram with ST-segment elevation greater than or equal to 0.2 mV in at least 2 contiguous leads;
• Choice of primary angioplasty

Exclusion Criteria:

• Prior acute myocardial infarction;
• Prior heart failure;
• Angioplasty in the last 3 months;
• Cardiac arrest or cardiogenic shock;
• History of renal insufficiency (serum creatinine greater than 2.0 mg/dl);
• History of alcohol abuse (consumption equal to or greater than 20 drinks per week);
• Illicit drug use;
• Evidence of rheumatoid arthritis;
• Neoplasia;
• Infectious diseases;
• Prior anemia (hematocrit below 30%);
• Use of anti-inflammatory hormonal or non-hormonal last week;
• Xanthines excessive consumption (more than two and a half cups of coffee or two and a half mate gourds);
• Pregnancy;
• Disagreement with the term of consent;