Quantitative MRI to define mechanisms of CArDiovascular co-morbidity in patients with Early Rheumatoid Arthritis and to measure the effect of biological therapy

Phase 4

Completed

• Conditions: Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis; Circulatory System

• Registration Number: ISRCTN50167738
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

1. 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25381560 2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27895040

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-08
• Study Completion: 2015-01-31
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients:
1. Males and females
2. Aged between 18 and 80 years
3. Diagnosed with RA according to 2010 ACR/EULAR criteria
4. Who have not yet received therapy with disease modifying drugs
5. Have early (symptoms for less than 1 year)
6. Active disease (clinical or imaging evidence of synovitis and DAS28- ESR >/= 3.2)
7. At least one poor prognostic factor (anti-citrullinated peptide antibody +/- abnormal power Doppler in at least 1 joint)

Controls:
1. Males and females without RA
2. Aged between 18 and 80 years
3. Matched for age and blood pressure

Exclusion Criteria

Patients:
1. Previous treatment with DMARDs
2. Contraindications to MRI and to anti-TNF therapy and severe co-morbidity that would in the clinician?s opinion be associated with unacceptable risk of receiving potentially anti-TNF therapy
3. Contraindications to MRI (incompatible metallic implants, pacemakers)
4. Renal failure (eGFR<30 ml/min/1.73m2)
5. Previous allergic reactions to MRI contrast agents
6. Known cardiovascular disease (CVD)
7. Contraindications to adenosine (asthma or high grade heart block)

Controls:
1. History of RA or other inflammatory disease
2. Contraindications to MRI
3. Contrast agents or adenosine or presence of renal failure as defined above
4. Known CVD

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main outcome measures in this study are quantitative MRI measurements. Longitudinal changes of outcome measures in response to therapy will be measured and compared between the two treatment arms. Differences in outcome measures between the patient and control groups will be established.<br><br>1. Aortic distensibility

Secondary Outcome Measures

Name	Time	Method
1. Left ventricle (LV) ejection fraction<br>2. LV strain and twist<br>3. Myocardial perfusion reserve