Myocardial Infarction | The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)
Myocardial Infarction research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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;
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MethotrexateThe 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
Drug:RiboflavinWe 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MethotrexateEstablished treatment associated with methotrexate
Placebo (Riboflavin)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.
Start Date: April 2013
Completed Date: December 2014
Phase: Phase 2
Primary Outcome: Area under the curve of creatine kinase
Secondary Outcome: Area under the curve for creatine kinase MB fraction and troponin I high sensitive
Study sponsors, principal investigator, and references
Principal Investigator: Daniel M. Moreira, MD. MSc.
Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul
Collaborator: Instituto de Cardiologia de Santa Catarina