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
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|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|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|
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.
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
|Contact: Hector Chinoy, PhD MRCP||+44 161 firstname.lastname@example.org|
|Contact: Robert G Cooper, MD FRCP||+44 161 email@example.com|
|Welcome Trust Clinical Research Facility||Recruiting|
|Manchester, United Kingdom, M13 9WL|
|Principal Investigator:||Hector Chinoy, PhD MRCP||Salford Royal NHS Foundation Trust|