Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating cardiovascular abnormalities in people with immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis and systemic lupus erythematosus. The goal is to find new clinical, blood, and imaging biomarkers that can help diagnose, predict, and understand heart disease risks in IMID patients. This observational study aims to fill gaps in knowledge about why some IMID patients develop cardiovascular disease (CVD) while others do not, to improve future patient care. Participants with IMID will be recruited from rheumatology and cardiology departments as inpatients or outpatients. The study includes groups of IMID patients at risk of CVD, those with new or previous major cardiovascular events, and control groups including patients with CVD but no IMID, IMID patients without CVD, and healthy volunteers. Participants may also join sub-studies involving additional biological sample collection or advanced imaging tests like echocardiography and cardiovascular magnetic resonance imaging. During the study, researchers will collect past, current, and ongoing medical information, including routine blood tests, imaging, and questionnaires at scheduled visits generally every six months initially, then annually. Additional tests in sub-studies may be combined with routine care. Researchers will monitor clinical outcomes such as major cardiovascular events over ten years. Participant information will be securely stored, and all procedures will be done by trained NHS staff to minimize inconvenience.
CONDITIONS
Brief Title
Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Able to provide informed consent
- Clear diagnosis of an immune-mediated inflammatory disease (IMID)
- For main study: IMID patients either at risk of cardiovascular disease (CVD), with new major cardiovascular events, or with previous events
- Controls: adults 18 or older with no IMID or CVD diagnosis
- Willing to participate in questionnaires and clinical data collection
You will not qualify if you...
- Under 18 years of age
- Unable to give informed consent
- For imaging sub-study: having pacemakers, certain implants, metal fragments in head or eye, pregnancy or breastfeeding
- Kidney function below a specified level (GFR < 30 ml/min/1.73 m2) if receiving contrast agents for imaging
- Any condition preventing safe participation in imaging studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Up to 10 years
Participants have their health monitored through routine clinical visits, laboratory tests, and imaging assessments as part of their usual clinical care. This includes evaluations for cardiovascular disease risk and immune-mediated inflammatory disease activity.
Visits typically every 6 months initially, then annually thereafter, with additional visits as needed according to clinical care
Duration - Variable throughout study duration
Participants consenting to the Imaging Sub-Study undergo additional imaging tests such as echocardiography, cardiac MRI, and peripheral vascular imaging to gather detailed cardiovascular data beyond routine care.
Additional visits separate from routine clinical visits as required for imaging assessments
Duration - At baseline and possibly repeated at clinical status changes or specific time points
Participants consenting to the Biological Sub-Study provide biological samples, including blood and possibly urine, to support experimental studies on cardiovascular and immune mechanisms.
Additional blood draws typically coordinated with routine clinical visits to minimize inconvenience
Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
J
James Lawrence, MSc
M
Maya H Buch, MD
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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