Understanding heart problems in patients with immune-related diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.