Rationale and design of the TETHYS trial: the effects of methotrexate therapy on myocardial infarction with ST-segment elevation.

INTRODUCTION: Methotrexate is a drug that has shown anti-ischemic effects in animal studies and positive results in heart failure clinical trials. METHODS: We will randomly assign 80 patients with acute myocardial infarction to receive methotrexate (0.05 mg/kg bolus followed by 0.05 mg/kg/h for 6 h) or matching placebo. The primary outcome will be the area under the curve (AUC) for creatine kinase (CK) release for 72 h. Secondary outcomes will be the peak levels of CK, CK-MB fraction and troponin I, AUC for CK-MB and troponin I, levels of B-type natriuretic peptide (BNP), high-sensitivity C-reactive protein (hsCRP) and erythrocyte sedimentation rate (ESR) at admission and at 30 days, left ventricular ejection fraction (LVEF) at baseline and at 30 days, death, TIMI (thrombolysis in myocardial infarction) frame count in the culprit artery, Killip score after 72 h and rate of reinfarction at 30 days. RESULTS: We expect a reduction in the AUC for CK, CK-MB and troponin release in the methotrexate group compared to the placebo group. We also expect a reduction in the levels of BNP, hsCRP and ESR and an improvement of LVEF and TIMI frame count in the methotrexate group. CONCLUSION: This trial may be the first to demonstrate the anti-inflammatory and anti-ischemic effects of methotrexate in patients with acute myocardial infarction.

Safety and feasibility of transulnar cardiac catheterization.

Recently, ulnar artery cannulation has been described as an alternative to the transfemoral and radial approaches to vascular access for cardiac catheterization. This study was designed to evaluate the safety and feasibility of the ulnar approach.From September 2004 through September 2006, 28 patients in a cohort study underwent cardiac catheterization by the transulnar approach. Patients were eligible if they had scheduled an elective cardiac catheterization or angioplasty procedure and displayed a palpable ulnar pulse and a positive reverse Allen's test (< 10 sec). Further, we enrolled only patients who had stable angina. After cannulation, a 5F or 6F introducer was placed inside the vessel, and cardiac catheterization or angioplasty was performed. The patients underwent clinical examination when discharged from the hospital and again at the 1-week follow up.Mean age, weight, and height of the patients were 60 +/- 14 years, 78 +/- 14 kg, and 148 +/- 55 cm, respectively, and 69% were men. Successful puncture was achieved in 93% (26/28), and in all 26 of these patients the procedure could be completed by the ulnar approach. The femoral approach was used for the remaining 2 patients. No cases of arterial spasm or loss of pulse were observed. Two patients had minor hematoma at the entry site. There were no cases of pseudoaneurysm, bleeding episodes requiring transfusion, or vascular perforation.We conclude that the transulnar approach is a safe and feasible alternative for diagnostic and therapeutic coronary intervention.