Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases

Launched by UNIVERSITY OF MANCHESTER · Sep 17, 2024

Keywords

ClinConnect Summary

The Greater Manchester CARDIOvascular Pathology trial is studying how heart problems are related to immune-mediated inflammatory diseases (IMID), such as certain rheumatologic conditions. The researchers want to identify new ways to diagnose and predict heart disease in patients with these conditions by looking at clinical information, blood tests, and imaging results. Understanding these connections better could lead to improved treatments for patients in the future.

To participate, individuals must be over 18 years old, have a diagnosed IMID, and be capable of giving informed consent. Participants will be asked to share their medical history, undergo routine heart imaging, and complete questionnaires. Some may also take part in additional studies involving blood and urine samples or advanced heart imaging techniques. The trial is currently recruiting at specialist NHS centers, starting at Manchester University Hospitals NHS Foundation Trust, and aims to include both individuals with IMID and healthy volunteers for comparison.

Gender

ALL

Eligibility criteria

• • 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.