Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478277
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-10
Brief Title:
UK CARDIOvascular Immune-Mediated Inflammatory Diseases CARDIO-IMID Registry Study
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
Official Title:
The UK CARDIOvascular Immune-Mediated Inflammatory Diseases CARDIO-IMID Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARDIO-IMID
Brief Summary:
The goal of this observational study is to develop a large deeply characterised cohort that will be a platform for collaborative clinical and translational research into cardiovascular CV disease CVD and Immune-mediated-inflammatory-diseases IMID The main aim is to evaluate whether existing blood cardiac biomarkers predict adverse cardiovascular outcomes The study will capture standard of care CV and associated health data clinical biochemistrypathology and investigations in patients across the IMIDs Optional biological andor imaging sub-studies will provide additional data andor samples for associated analyses
Detailed Description:
Multimorbidity is a rapidly growing burden on our healthcare systems especially with an ageing demographic CVD is a major cause of morbidity and mortality The co-association of IMIDs with CVD needs more sophisticated understanding of the underlying risk earlier identification and tailored use of targeted therapeutics Importantly the investigation of CVD in IMID offers an effective human experimental model to improve not just the lives of people with IMIDs but also the general CVD population
The UK CARDIOvascular Immune-Mediated Inflammatory Diseases CARDIO-IMID registry will be a key platform for United Kingdom UK multi-centre clinical and translational CARDIO-IMID research The aim is that centres across the UK including all the devolved nations will collaborate and contribute patients such that the registry will provide deep phenotyping linked to clinical outcomes in ultimately many hundreds of patients The planned study will establish a deeply phenotyped cohort andor as part of the optional sub-study an associated bioresource to support individual discrete studies andor analyses that address the stated aims and objectives All potential participants will be invited to participate in the longitudinal collection and evaluation of routine comprehensive clinical information including pathology imaging and other cardiovascular data This programme will identify patients within defined IMID clinical cohorts at different stages of rheumatology and cardiovascular disease These data will be invaluable in enabling a full characterisation of CVD in terms of the extent presentation risk factors and pathophysiology Patients are seen as per standard clinical practice determined by the index IMID and in this setting also dependent on co-existing CV comorbidity usually every 3-6 months at time of IMIDCVD diagnosis and then 6 to 12 monthly thereafter Specific questionnaires and tests requested outside of standard of care sub-studies will depend on disease group and clinical context Not all patients will be required to complete all the relevant questionnaires instead based on individual IMID andor CVD profile
In addition there is the opportunity for subjects to include i longitudinal biological blood samples and ii extended cardiovascular magnetic resonance CMR imaging protocol for those receiving CMR as part of National Health Service NHS standard of care
Collectively the study and associated platform with appropriate biostatistical and machine learning approaches will inform on the pathophysiological sequence of events identification of prognostic biomarkers and risk models as well as enable evaluation of the influence of IMID-specific vascular - immunosuppressive therapies and traditional cardiac pharmacotherapy where indicated It will also establish a platform for trials in IMIDs to capture CV outcomes Moreover it will provide cohorts of patients readily available for recruitment with linkage in place for outcomes It could be used to leverage commercial funding and participation facilitated by simplified single-point access for industry It will enable scaled investigation aimed at understanding causes of CARDIO-IMID improving risk stratification and providing better care
The UK CARDIOvascular Immune-Mediated Inflammatory Diseases CARDIO-IMID registry will be a key platform for United Kingdom UK multi-centre clinical and translational CARDIO-IMID research The aim is that centres across the UK including all the devolved nations will collaborate and contribute patients such that the registry will provide deep phenotyping linked to clinical outcomes in ultimately many hundreds of patients The planned study will establish a deeply phenotyped cohort andor as part of the optional sub-study an associated bioresource to support individual discrete studies andor analyses that address the stated aims and objectives All potential participants will be invited to participate in the longitudinal collection and evaluation of routine comprehensive clinical information including pathology imaging and other cardiovascular data This programme will identify patients within defined IMID clinical cohorts at different stages of rheumatology and cardiovascular disease These data will be invaluable in enabling a full characterisation of CVD in terms of the extent presentation risk factors and pathophysiology Patients are seen as per standard clinical practice determined by the index IMID and in this setting also dependent on co-existing CV comorbidity usually every 3-6 months at time of IMIDCVD diagnosis and then 6 to 12 monthly thereafter Specific questionnaires and tests requested outside of standard of care sub-studies will depend on disease group and clinical context Not all patients will be required to complete all the relevant questionnaires instead based on individual IMID andor CVD profile
In addition there is the opportunity for subjects to include i longitudinal biological blood samples and ii extended cardiovascular magnetic resonance CMR imaging protocol for those receiving CMR as part of National Health Service NHS standard of care
Collectively the study and associated platform with appropriate biostatistical and machine learning approaches will inform on the pathophysiological sequence of events identification of prognostic biomarkers and risk models as well as enable evaluation of the influence of IMID-specific vascular - immunosuppressive therapies and traditional cardiac pharmacotherapy where indicated It will also establish a platform for trials in IMIDs to capture CV outcomes Moreover it will provide cohorts of patients readily available for recruitment with linkage in place for outcomes It could be used to leverage commercial funding and participation facilitated by simplified single-point access for industry It will enable scaled investigation aimed at understanding causes of CARDIO-IMID improving risk stratification and providing better care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None