Cardiovascular effects of tumour necrosis factor alpha antagonism in patients with acute myocardial infarction: a first in man study

niversity of Edinburgh (UK)0 个研究点目标入组 26 人开始时间: 2013年1月14日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

niversity of Edinburgh (UK)