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

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ClinicalTrials.gov Identifier: NCT00971828
Recruitment Status : Unknown
Verified October 2009 by Salford Royal NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : September 4, 2009
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Salford Royal NHS Foundation Trust

Study Description
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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

Resource links provided by the National Library of Medicine


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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971828


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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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    Key Record Dates
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