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 sites14 target enrollmentApril 11, 2008

Overview

No summary available.

Registry

who.int

Start Date

April 11, 2008

End Date

April 30, 2014

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Kings College London

•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

•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