Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial

Bara Erhayiem; Sue Pavitt; Paul Baxter; Jacqueline Andrews; John P Greenwood; Maya H Buch; Sven Plein

doi:10.1186/1745-6215-15-436

Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial

Bara Erhayiem, Sue Pavitt, Paul Baxter, Jacqueline Andrews, John P Greenwood, Maya H Buch, Sven Plein

Division of Musculoskeletal & Dermatological Sciences (L5)

University of Leeds

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: The incidence of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is increased compared to the general population. Immune dysregulation and systemic inflammation are thought to be associated with this increased risk. Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm. It remains unclear, however, whether using tumor necrosis factor inhibitors (TNFi) to achieve remission confer additional beneficial effects over standard therapy, especially on the development of CVD.

METHODS/DESIGN: Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA) is a prospective cardiovascular imaging study that bolts onto an existing single-centre, randomized controlled trial, VEDERA (Very Early versus Delayed Etanercept in Rheumatoid Arthritis). VEDERA will recruit 120 patients with early, treatment-naïve RA, randomized to TNFi therapy etanercept (ETN) combined with methotrexate (MTX), or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a 'treat-to-target' regimen. VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance (CMR) assessment with; cine imaging, rest/stress adenosine perfusion, tissue-tagging, aortic distensibility, T1 mapping and late gadolinium imaging. Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period. All patients will enter an inflammatory arthritis registry for long-term follow-up.

DISCUSSION: CADERA is a multi-parametric study describing cardiovascular abnormalities in early, treatment-naïve RA patients, with assessment of changes at one year between early biological therapy and conventional therapy.

TRIALS REGISTRATION: This trial was registered with Current Controlled Trials (registration number: ISRCTN50167738) on 8 November 2013.

Original language	English
Pages (from-to)	436
Journal	Trials
Volume	15
DOIs	https://doi.org/10.1186/1745-6215-15-436
Publication status	Published - 8 Nov 2014

Keywords

Antirheumatic Agents/adverse effects
Arthritis, Rheumatoid/diagnosis
Clinical Protocols
Contrast Media
Coronary Artery Disease/diagnosis
Drug Therapy, Combination
England/epidemiology
Etanercept
Humans
Immunoglobulin G/therapeutic use
Magnetic Resonance Imaging, Cine
Methotrexate/therapeutic use
Predictive Value of Tests
Prevalence
Prospective Studies
Receptors, Tumor Necrosis Factor/therapeutic use
Research Design
Time Factors
Treatment Outcome
Tumor Necrosis Factor-alpha/antagonists & inhibitors

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/1745-6215-15-436

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@article{4f45bae49316470fbfb5062c0bf4e501,

title = "Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial",

abstract = "BACKGROUND: The incidence of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is increased compared to the general population. Immune dysregulation and systemic inflammation are thought to be associated with this increased risk. Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm. It remains unclear, however, whether using tumor necrosis factor inhibitors (TNFi) to achieve remission confer additional beneficial effects over standard therapy, especially on the development of CVD.METHODS/DESIGN: Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA) is a prospective cardiovascular imaging study that bolts onto an existing single-centre, randomized controlled trial, VEDERA (Very Early versus Delayed Etanercept in Rheumatoid Arthritis). VEDERA will recruit 120 patients with early, treatment-na{\"i}ve RA, randomized to TNFi therapy etanercept (ETN) combined with methotrexate (MTX), or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a 'treat-to-target' regimen. VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance (CMR) assessment with; cine imaging, rest/stress adenosine perfusion, tissue-tagging, aortic distensibility, T1 mapping and late gadolinium imaging. Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period. All patients will enter an inflammatory arthritis registry for long-term follow-up.DISCUSSION: CADERA is a multi-parametric study describing cardiovascular abnormalities in early, treatment-na{\"i}ve RA patients, with assessment of changes at one year between early biological therapy and conventional therapy.TRIALS REGISTRATION: This trial was registered with Current Controlled Trials (registration number: ISRCTN50167738) on 8 November 2013.",

keywords = "Antirheumatic Agents/adverse effects, Arthritis, Rheumatoid/diagnosis, Clinical Protocols, Contrast Media, Coronary Artery Disease/diagnosis, Drug Therapy, Combination, England/epidemiology, Etanercept, Humans, Immunoglobulin G/therapeutic use, Magnetic Resonance Imaging, Cine, Methotrexate/therapeutic use, Predictive Value of Tests, Prevalence, Prospective Studies, Receptors, Tumor Necrosis Factor/therapeutic use, Research Design, Time Factors, Treatment Outcome, Tumor Necrosis Factor-alpha/antagonists & inhibitors",

author = "Bara Erhayiem and Sue Pavitt and Paul Baxter and Jacqueline Andrews and Greenwood, {John P} and Buch, {Maya H} and Sven Plein",

year = "2014",

month = nov,

day = "8",

doi = "10.1186/1745-6215-15-436",

language = "English",

volume = "15",

pages = "436",

journal = "Trials",

issn = "1745-6215",

publisher = "Springer Nature",

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TY - JOUR

T1 - Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA)

T2 - study protocol for a randomized controlled trial

AU - Erhayiem, Bara

AU - Pavitt, Sue

AU - Baxter, Paul

AU - Andrews, Jacqueline

AU - Greenwood, John P

AU - Buch, Maya H

AU - Plein, Sven

PY - 2014/11/8

Y1 - 2014/11/8

N2 - BACKGROUND: The incidence of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is increased compared to the general population. Immune dysregulation and systemic inflammation are thought to be associated with this increased risk. Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm. It remains unclear, however, whether using tumor necrosis factor inhibitors (TNFi) to achieve remission confer additional beneficial effects over standard therapy, especially on the development of CVD.METHODS/DESIGN: Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA) is a prospective cardiovascular imaging study that bolts onto an existing single-centre, randomized controlled trial, VEDERA (Very Early versus Delayed Etanercept in Rheumatoid Arthritis). VEDERA will recruit 120 patients with early, treatment-naïve RA, randomized to TNFi therapy etanercept (ETN) combined with methotrexate (MTX), or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a 'treat-to-target' regimen. VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance (CMR) assessment with; cine imaging, rest/stress adenosine perfusion, tissue-tagging, aortic distensibility, T1 mapping and late gadolinium imaging. Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period. All patients will enter an inflammatory arthritis registry for long-term follow-up.DISCUSSION: CADERA is a multi-parametric study describing cardiovascular abnormalities in early, treatment-naïve RA patients, with assessment of changes at one year between early biological therapy and conventional therapy.TRIALS REGISTRATION: This trial was registered with Current Controlled Trials (registration number: ISRCTN50167738) on 8 November 2013.

AB - BACKGROUND: The incidence of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is increased compared to the general population. Immune dysregulation and systemic inflammation are thought to be associated with this increased risk. Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm. It remains unclear, however, whether using tumor necrosis factor inhibitors (TNFi) to achieve remission confer additional beneficial effects over standard therapy, especially on the development of CVD.METHODS/DESIGN: Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA) is a prospective cardiovascular imaging study that bolts onto an existing single-centre, randomized controlled trial, VEDERA (Very Early versus Delayed Etanercept in Rheumatoid Arthritis). VEDERA will recruit 120 patients with early, treatment-naïve RA, randomized to TNFi therapy etanercept (ETN) combined with methotrexate (MTX), or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a 'treat-to-target' regimen. VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance (CMR) assessment with; cine imaging, rest/stress adenosine perfusion, tissue-tagging, aortic distensibility, T1 mapping and late gadolinium imaging. Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period. All patients will enter an inflammatory arthritis registry for long-term follow-up.DISCUSSION: CADERA is a multi-parametric study describing cardiovascular abnormalities in early, treatment-naïve RA patients, with assessment of changes at one year between early biological therapy and conventional therapy.TRIALS REGISTRATION: This trial was registered with Current Controlled Trials (registration number: ISRCTN50167738) on 8 November 2013.

KW - Antirheumatic Agents/adverse effects

KW - Arthritis, Rheumatoid/diagnosis

KW - Clinical Protocols

KW - Contrast Media

KW - Coronary Artery Disease/diagnosis

KW - Drug Therapy, Combination

KW - England/epidemiology

KW - Etanercept

KW - Humans

KW - Immunoglobulin G/therapeutic use

KW - Magnetic Resonance Imaging, Cine

KW - Methotrexate/therapeutic use

KW - Predictive Value of Tests

KW - Prevalence

KW - Prospective Studies

KW - Receptors, Tumor Necrosis Factor/therapeutic use

KW - Research Design

KW - Time Factors

KW - Treatment Outcome

KW - Tumor Necrosis Factor-alpha/antagonists & inhibitors

U2 - 10.1186/1745-6215-15-436

DO - 10.1186/1745-6215-15-436

M3 - Article

C2 - 25381560

SN - 1745-6215

VL - 15

SP - 436

JO - Trials

JF - Trials

ER -

Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial

Abstract

Keywords

UN SDGs

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