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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:

Study Description
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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Detailed Description:

This study will be coordinated 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 be observed of differences between cases and controls.

Thirty UK Caucasian adult IIM cases, confimed by internationally accepted criteria, will be recruited via the Adult Onset Myositis clinic, Salford Royal NHS Foundation Trust. Age, gender and racematched controls will be recruited on a 'best friend' system. STUDY METHODS:In order to establish whether CHD risk is increased in patients with myositis, we would like to perform a pilot study, comparing the cardiovascular risk factors of 30 patient's from Salford Royal's adult myositis clinic, with a group of 30 healthy controls. Participant would be invited along to the Wellcome Trust Clinical Research Facility (WTCRF), where all the necessary tests would be performed at a 'one off' study visit. Participants would be asked to bring along a friend of the same gender and roughly the same age, who would then comprise the 'healthy control' comparison group.

The study would involve a consultant clinician completing a 'heart disease questionnaire' for each of the participants.

A single blood sample would be taken to check their blood sugar levels and cholesterol, and if they had myositis, disease activity would also be assessed. The non invasive diagnostic testing would include an ultrasound of the blood vessels of the neck, checking for narrowing of the arteries, and a special blood pressure test, looking for the early signs of atherosclerosis (build up of fat in the blood vessels). An electrocardiogram (ECG) would be performed, and if they have myositis, an ultrasound test of their heart (echocardiogram), would also be performed. A gadoliniumenhanced magnetic resonance scan (GdDTPAMRI) of the heart will be performed to examine for inflammation of the heart tissue (pericardium and myocardium). The echo and MR will only be performed in patients, and not controls.

If the study demonstrated that patients with myositis had more chance of developing CHD, than those in the control group, this would have implications for their future clinical care, requiring close monitoring of patients for the early signs of CHD, and the appropriate intervention when necessary. This study will be funded by the WTCRF Small Grants Award Scheme.MORE DETAILED DESCRIPTION OF STUDY METHODS:Cases and controls will have the following recorded for assessment of cardiovascular risk factors: i) Standardised questionnaire to ascertain basic details, e.g. age, ethnicity, medical and family history, drug use and smoking. ii) Height and weight measurement. iii) Blood tests, including fasting blood sugar, lipid profile & Creactive protein. iv) Lean body mass measurement using a body composition analyser. v) Electrocardiogram. v) Subclinical atherosclerosis measurement using Bmode ultrasound CIMT. vi) Endothelial dysfunction measurement using EndoPAT.

Cases will additionally have the following to assess disease status:

i) Clinical assessment of myositis disease activity (MITAX/MYOACT) and disease damage (MDI, MYODAM). ii) Assessment of muscle strength using manual muscle testing. iii) Further bloods including serum creatine kinase, erythrocyte sedimentation rate, serology including antiphospholipid status. iv) Assessment of left ventricular/septal dysfunction, and pericardial abnormalities using contrast echocardiography. vi) Assessment of the diagnostic utility of GdDTPAMRI to assess myocardial disease activity in the presence of cardiovascular disease. All procedures will be conducted by a technician or nurse employed within the WTCRF. The clinical and muscle strength assessment will be performed by a medical practitioner (to be appointed).

At the WTCRF, The University of Manchester, facilities are already available for Bmode ultrasound CIMT measurement, EndoPAT, 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, Bmode ultrasound carotid artery narrowing and EndoPAT. IIM cases will have additional blood tests and a clinical assessment to assess their disease status. As part of a linked study, subjects (but not controls) will also have GdDTPAMRI and contrast echocardiography of the heart performed. The primary research end point will be the detection of significant patient/control group differences.


Study Design

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


Groups and Cohorts

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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

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