Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06600737

Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases

Led by University of Manchester · Updated on 2024-09-19

325

Participants Needed

1

Research Sites

413 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females
  • Age over 18 years
  • Able to provide informed consent and sign a consent form
  • Diagnosed with an immune-mediated inflammatory disease (IMID) with one of the following: at risk of cardiovascular disease (CVD) but no major adverse cardiovascular events (MACE), new (incident) IMID-CVD with MACE, or established IMID-CVD with previous MACE
  • For controls: age 18 or older, able to consent, no known IMID for CVD-no IMID and healthy controls, no known CVD for IMID-no risk CVD and healthy controls
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Unable to provide informed consent
  • For cardiac MRI imaging: presence of pacemakers, surgical clips in the head, certain inner ear implants, neuro-electrical stimulators, metal fragments in eye or head, pregnancy or breastfeeding
  • For MRI with gadolinium contrast: glomerular filtration rate (GFR) less than 30 ml/min/1.73 m2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

J

James Lawrence, MSc

CONTACT

M

Maya H Buch, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

8

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