Acute myocardial infarction Circulatory System Acute myocardial infarction, unspecified
Conditions
Interventions
Patients presenting with acute myocardial infarction randomised to received an intravenous infusion of etanercept (10 mg) or saline placebo over 30 minutes.
Sponsors
University of Edinburgh (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A typical history of myocardial ischaemia lasting more than 20 minutes within 24 hours prior to admission 2. An elevated troponin I(>0.1µg/L) and/or electrocardiographic changes 3. Age =18 years of age, either sex 4. Screening full blood count (FBC) must meet the following criteria: healmoglobin (Hb) > 85g/L, white cell count (WCC) > 3.5 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L 5. Subjects must be able to adhere to the study visit schedule and other protocol requirements 6. The subject must be capable of giving informed consent and the consent must be obtained prior to screening procedures
Exclusion criteria
Exclusion criteria: 1. Women of child bearing potential 2. Systolic blood pressure >190mmHg or <100mmHg 3. Malignant arrhythmias 4. Renal or hepatic failure 5. Severe or significant co-morbidity 6. Previous history of blood dyscrasia 7. Unable to tolerate the supine position 8. Opportunistic infection within the previous 6 months, human immunodeficiency virus, serious infection within the previous 2 months, chronic/recurrent infection 9. A history of malignancy within the previous 5 years, lymphoproliferative disease, or multiple sclerosis/ other demyelinating disorder 10. Patients with diabetes mellitus (type 1 or insulin-dependent) 11. Patients with systemic inflammatory disorder 12. Use of any investigational drug within 1 month prior to screening or within five half-lives of investigational agent, whichever is longer 13. Treatment with any other therapeutic agent targeted at reducing TNF (e...g pentoxifylline, thalidomide, etanercept etc) within 3 months of screening 14. Known recent substance abuse (drugs or alcohol) 15. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet monocyte aggregation, peripheral vasomotor and fibrinolytic function at baseline and again 24 hours later | — |
Secondary
| Measure | Time frame |
|---|---|
| Leukocyte count and plasma cytokine concentrations at baseline and again 24 hours later | — |
Countries
United Kingdom
Outcome results
None listed