Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00971828 |
| Other study ID # |
Chinoy-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2011 |
| Est. completion date |
September 2012 |
Study information
| Verified date |
April 2022 |
| Source |
Northern Care Alliance NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
