Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
The researchers would like to know more about cardiovascular abnormalities in patients with immune-mediated inflammatory diseases (IMID) and with the aim to provide new biomarkers (clinical, blood, imaging) for early diagnosis, prognosis and prediction of CVD in patients with IMID. This is important as there are still many things that are not known about this and finding out more could improve how patients are treated in future.
Participants with IMID diagnoses will be recruited from rheumatology/cardiology departments as in-patients or outpatients.
Once consented, researchers will collect past, present and future clinical information about them, including routine cardiovascular imaging and blood tests. Participants will also be asked to complete questionnaires at predetermined intervals. The participants could also be approached to take part in the following sub-studies; Biological sub-study, in which blood and urine would be collected; And the Imaging-sub study, in which one or more of Echocardiography, Cardiovascular Magnetic Resonance Imaging (CMR) and Laser Doppler Imaging (LDI) will be performed. Participants with CVD without IMID and healthy volunteers will also be recruited as comparison groups.
The research is to be funded by the NIHR Manchester BRC ('Integrated Cardiovascular' and 'Rheumatic \& Musculoskeletal Diseases' themes). Other funding eg Manchester Academic Health Sciences and a recently awarded Medical Research Council Partnership grant will also support this programme. The study will recruit in specialist NHS centres; Recruitment will start in Manchester University Hospitals NHS Foundation Trust.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females
Subjects aged over 18 years
Capable of providing informed consent and signing a consent form
IMID-'at risk' CVD: individuals who have a risk of developing CVD (based on traditional risk factors and/or IMID-specific factors) but no history of major adverse cardiovascular events (MACE).
Disqualifiers
Age less than 18 years
Lack of capacity to give informed consent
As-listed for Main Study and;
For the research cardiac MRI imaging component, the following exclusions will apply: pacemakers, surgical clips within the head, certain inner ear implants, neuro-electrical stimulators or metal fragments within the eye or head, pregnancy or breast-feeding. For administration of gadolinium-based contrast agent, GFR < 30 ml/min/1.73 m2 is a contraindication.
Trial population
Participants will be recruited from NHS secondary care in the United Kingdom. Potential participants may be identified from clinics, wards, diagnostic pathways and departments, electronic and paper-based health records, databases and waiting lists in secondary care. All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
325 Participants
are grouped into 8 trial groups8
Trial groupsSee each trial group below.
Group A: Disease Control (IMID and no CV disease)
Group B: Disease Control (CV disease and no IMID)
Group C: Healthy Control (no IMID history or CV disease)
Group D: Main Study (IMID 'at risk' CVD)
Group E: Main Study (Incident (new) IMID-CVD)
Group F: Main Study (Established IMID-CVD)
Group G: Imaging Sub-Study
Group H: Biological Sub-Study
Trial outcomes
Primary outcomes
1
Number of participants with major adverse cardiovascular events (MACE)
Major Adverse Cardiovascular Events (MACE) is a grouped term typically defined as acute myocardial infarction, stroke or cardiovascular death. Primary myocardial events such as myocarditis (especially relevant to IMIDs such as SSc, IIM, SLE) will also form part of the primary MACE definition. The total number of participants presenting with or developing a MACE will be measured. Unit: number of participants
Time frame
10 YearsSecondary outcomes
1
Number of participants with heart failure hospitalisations
Extended MACE endpoints that may comprise all ischaemic CV events/significant clinical outcomes will also be captured: Heart failure hospitalisation, unstable angina, need for revascularisation, all-cause mortality. The total number of participants hospitalised with heart failure will be measured. Unit: number of participants
Time frame
10 Years2
Number of participants with unstable angina
Extended MACE endpoints that may comprise all ischaemic CV events/significant clinical outcomes will also be captured: Heart failure hospitalisation, unstable angina, need for revascularisation, all-cause mortality. The total number of participants with unstable angina will be measured. Unit: number of participants
Time frame
10 Years3
Number of participants needing revascularisation
Extended MACE endpoints that may comprise all ischaemic CV events/significant clinical outcomes will also be captured: Heart failure hospitalisation, unstable angina, need for revascularisation, all-cause mortality. The total number of participants needing revascularisation will be measured. Unit: number of participants
Time frame
10 Years4
Number of participants with abnormal high-sensitivity cardiac troponin I/T levels
The total number of participants with abnormal high-sensitivity troponin I/T levels (assessed by blood draw) will be measured. Unit: number of participants
Time frame
10 YearsSponsors and contacts
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Source ClinicalTrials.gov