Understanding heart problems in patients with immune-related diseases
Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
This study is trying to find out more about heart problems in people with immune-related diseases like rheumatoid arthritis and lupus to help catch and treat these issues earlier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 325 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manchester Academic / other |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT06600737 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate cardiovascular abnormalities in patients with immune-mediated inflammatory diseases (IMID) such as rheumatoid arthritis and systemic lupus erythematosus. Researchers will collect clinical information, imaging data, and blood samples from participants to identify new biomarkers for early diagnosis and prognosis of cardiovascular disease (CVD) in this population. Participants will be recruited from rheumatology and cardiology departments and will complete questionnaires at various intervals. The study seeks to address the significant morbidity and mortality associated with CVD in IMID patients by improving early identification and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a clear diagnosis of an immune-mediated inflammatory disease and varying histories of cardiovascular disease.
Not a fit: Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and treatment of cardiovascular disease in patients with immune-mediated inflammatory diseases.
How similar studies have performed: While there is ongoing research in this area, this study aims to fill significant knowledge gaps regarding cardiovascular risks in IMID patients, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Maya H Buch, MD — University of Manchester
- Study coordinator: James Lawrence, MSc
- Email: james.lawrence@manchester.ac.uk
- Phone: +44 161 306 5679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.