Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Salford Royal NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Salford Royal NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00971828
First received: September 3, 2009
Last updated: August 12, 2011
Last verified: October 2009
  Purpose

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
Idiopathic Inflammatory Myopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Case-control Study to Assess Risk of Coronary Heart Disease in Idiopathic Inflammatory Myopathy

Resource links provided by NLM:


Further study details as provided by Salford Royal NHS Foundation Trust:

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.


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Hector Chinoy, Salford Royal NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00971828     History of Changes
Other Study ID Numbers: Chinoy-001
Study First Received: September 3, 2009
Last Updated: August 12, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Salford Royal NHS Foundation Trust:
Myositis
polymyositis
dermatomyositis

Additional relevant MeSH terms:
Muscular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Myositis
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014