EUCTR2007-005464-26-GB进行中（未招募）1 期
The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II
Kings College London0 个研究点目标入组 14 人开始时间: 2008年4月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male and female subjects over 18 years of age
- •2. Systemic inflammatory conditions (rheumatoid arthritis) diagnosis established independently by the clinical team
- •3. Eligiblilty for anti-TNF-alpha therapy- decision to start treatment reached independently by the clinical team.
- •4.Woman of childbearing potential must have a negative serum pregnancy test within 7 days of the first adminstration of study treatment, and must be willing to use a reliable form of contraception to prevent pregnancy.
- •5. Provision of signed, informed, consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Inability to tolerate scanning (claustrophobia, inability to lie flat);
- •2. Contra-indications to MRI (implantable devices, hypersensitivity to Gadolinium-
- •containing contrast agents, weight over 120kg);
- •3. Inability to give informed consent;
- •4. Non-sinus rhythm;
- •5. Above 70 years of age.
- •6. Diagnosis of tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections, chronic infection or a history of recurrent infection.
- •7. Moderate or severe heart failure (NYHA class III/IV)
- •8. Patients with a history of hypersensitivity to infliximab, entanercept, adalimumab or other murine proteins, or to any of the excipients
- •9. Concomitant use of immunosuppressive therapy, anakinra, abatacept, sulfasalazine
- •or live vaccinations
- •10. Patient with a history of Hepatitis B and C virus infection
- •11.Patients with a history of malignancy
- •12.Significantly impaired renal function (eGFR >60 ml/min/1.73m2)
- •13.Significantly impaired hepatic function (alkaline transaminase twice above the upper limit of the normal range)
- •14.Pre-existing blood dyscrasias, such as significant marrow hypoplasia, leukopenia,
- •thrombocytopenia or anaemia
- •15. Current pregnancy or lactation.
- •16. Patients with any significant history of non-compliance to medical regimens.
- •17. History of asthma, significant bradycardia and arrhythmias
- •18. Known hypersensitivity to adenosine
- •19. Known or suspected bronchostrictive or bronchospasti disease
- •20. Second- or third- degree atrioventricular (AV) block, sinus bradychardia (heart rate <45 bpm)
- •21. Systemic arterial hypotension (<90mm Hg)
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