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

NCT00971828 | Completed DMC

• 1 other identifier: Chinoy-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Inflammatory Myopathy

Keywords

Myositis; polymyositis; dermatomyositis

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Care Alliance NHS Foundation Trust: lead

Study Sites (1)

Welcome Trust Clinical Research Facility

Manchester, M13 9WL, United Kingdom

Location

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.

MeSH Terms

Conditions

Myositis; Polymyositis; Dermatomyositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Hector Chinoy, PhD MRCP

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

GB (1)