A Case-control Study to Assess Risk of Coronary Heart Disease in Idiopathic Inflammatory Myopathy

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study will be co-ordinated by Dr Hector Chinoy, Dr Robert G Cooper (Salford Royal NHS Foundation Trust / The University of Manchester) and Dr Ian N Bruce (Central Manchester University Hospitals NHS Foundation Trust/ The University of Manchester). An initial pilot study will be completed, to establish proof of concept of the study and to examine whether trends may observed of differences between cases and controls.

Twenty five prevalent UK Caucasian adult IIM cases, confirmed by internationally accepted criteria, will be recruited via the Adult Onset Myositis clinic, Salford Royal NHS Foundation Trust. Age, gender and race-matched controls will be recruited on a 'best friend' system. At the Wellcome Trust Clinical Research Facility (WTCRF), The University of Manchester, facilities are already available for B-mode ultrasound CIMT measurement, Endo-PAT, lean body mass measurement and contrast echocardiography. Cases and controls will have their cardiovascular risk factors assessed using a standardised questionnaire and blood tests. Further tests performed will include blood pressure, electrocardiogram, lean body mass, B-mode ultrasound CIMT measurement and Endo-PAT. IIM cases will have additional blood tests and a clinical assessment to assess their disease status, and contrast echocardiography. As part of a linked study, subjects (but not controls) will also have Gd-DTPA-MRI of the heart performed.

Condition or disease
Idiopathic Inflammatory Myopathy

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Study Design

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Study Type :	Observational
Estimated Enrollment :	30 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	A Case-control Study to Assess Risk of Coronary Heart Disease in Idiopathic Inflammatory Myopathy
Study Start Date :	July 2011
Estimated Primary Completion Date :	September 2012
Estimated Study Completion Date :	September 2012

Groups and Cohorts

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Group/Cohort

Idiopathic inflammatory myopathy; IIM patients will be recruited via the Adult Onset Myositis clinic, Salford Royal NHS Foundation Trust. Suitable patients will be asked if they are willing to partake in the study, via a letter, including a patient information leaflet. If willing, they will contact our study co-ordinator, who will facilitate the visit to the WTCRF. The patient will then sign a consent form and be able to enter the study.

Outcome Measures

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Biospecimen Retention:   Samples Without DNA

Bloods, including fasting blood sugar, lipid profile and C-reactive protein, serum creatine kinase, erythrocyte sedimentation rate, serology including antiphospholipid status.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

IIM patients will be recruited via the Adult Onset Myositis clinic, Salford Royal NHS Foundation Trust. Suitable patients will be asked if they are willing to partake in the study, via a letter, including a patient information leaflet. If willing, they will contact our study co-ordinator, who will facilitate the visit to the WTCRF. The patient will then sign a consent form and be able to enter the study.

Criteria

Inclusion Criteria:

• Subjects will be age, sex and race matched and willing to take part in the study.

Exclusion Criteria:

• Any subject below the age of 18 years, or
• Any subject with a personal or family history of past or current inflammatory or connective tissue diseases.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Hector Chinoy, PhD MRCP	+44 161 5162	hector.chinoy@manchester.ac.uk
Contact: Robert G Cooper, MD FRCP	+44 161 1483	robert.g.cooper@manchester.ac.uk

Locations

United Kingdom
Welcome Trust Clinical Research Facility	Recruiting
Manchester, United Kingdom, M13 9WL

Sponsors and Collaborators

Salford Royal NHS Foundation Trust

Investigators

Principal Investigator:	Hector Chinoy, PhD MRCP	Salford Royal NHS Foundation Trust

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr Hector Chinoy, Salford Royal NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00971828 History of Changes
Other Study ID Numbers:	Chinoy-001
First Posted:	September 4, 2009
Last Update Posted:	August 15, 2011
Last Verified:	October 2009

Keywords provided by Salford Royal NHS Foundation Trust:

Myositis; polymyositis; dermatomyositis

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Muscular Diseases; Myositis; Cardiovascular Diseases	Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases