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RECRUITING

NCT06600737

Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases

Sponsor: University of Manchester

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

325

Start Date

2024-09-30

Completion Date

2032-09-01

Last Updated

2024-09-19

Healthy Volunteers

Yes

Conditions

Cardiovascular Diseases Rheumatologic Disease

Main Study Inclusion Criteria: * Males and females * Subjects aged over 18 years * Capable of providing informed consent and signing a consent form * Have a clear diagnosis of an IMID with history consistent with one of the following categories: * 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). * Incident (new) IMID-CVD: Patients with IMID that present with a MACE. * Established IMID-CVD: Patients with IMID and a history of previous MACE Exclusion Criteria: * Age less than 18 years * Lack of capacity to give informed consent Imaging Sub-Study Inclusion Criteria: \- As-listed for Main Study Exclusion Criteria: * 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. Biological Sub-Study Inclusion Criteria: \- As-listed for Main Study Exclusion Criteria: \- As-listed for Main Study Controls Inclusion Criteria: * Subject ≥ 18 years of age * Is capable of understanding and signing an informed consent form * No known diagnosis of an IMID (CVD-no IMID disease control and healthy control groups) * No known diagnosis of CVD (IMID-no risk CVD disease control and healthy control groups) Exclusion Criteria: * 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. For Healthy controls: The researchers will aim to identify healthy controls using the 'bring a friend' strategy where the patient is asked to bring a friend/relative, thus minimising demographic bias. This will establish a healthy control pool. For specific analyses, controls will be age and sex matched and where possible, BMI-matched to the specific study population.

Locations (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom