Sponsor study identifier
observational
30
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2012
Actual (reported)Study Completion
September 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 3, 2009
Actual (reported)September 4, 2009
Actual (reported)July 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 2012
Actual (reported)September 2012
Actual (reported)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.
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.
Welcome Trust Clinical Research Facility
Manchester, M13 9WL, United Kingdom
Bloods, including fasting blood sugar, lipid profile and C-reactive protein, serum creatine kinase, erythrocyte sedimentation rate, serology including antiphospholipid status.
Hector Chinoy, PhD MRCP
Northern Care Alliance NHS Foundation Trust
30 participants (actual enrollment reported by the registry).
First Submitted
September 3, 2009
First Posted
September 4, 2009
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2012
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
April 14, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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