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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Collaborator: Instituto de Cardiologia de Santa Catarina
• Treatments: Methotrexate; Riboflavin

Criteria

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;