Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600737
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GM CARDIO-IMID
Brief Summary:
The researchers would like to know more about cardiovascular abnormalities in patients with immune-mediated inflammatory diseases IMID and with the aim to provide new biomarkers clinical blood imaging for early diagnosis prognosis and prediction of CVD in patients with IMID This is important as there are still many things that are not known about this and finding out more could improve how patients are treated in future
Participants with IMID diagnoses will be recruited from rheumatologycardiology departments as in-patients or outpatients
Once consented researchers will collect past present and future clinical information about them including routine cardiovascular imaging and blood tests Participants will also be asked to complete questionnaires at predetermined intervals The participants could also be approached to take part in the following sub-studies Biological sub-study in which blood and urine would be collected And the Imaging-sub study in which one or more of Echocardiography Cardiovascular Magnetic Resonance Imaging CMR and Laser Doppler Imaging LDI will be performed Participants with CVD without IMID and healthy volunteers will also be recruited as comparison groups
The research is to be funded by the NIHR Manchester BRC Integrated Cardiovascular and Rheumatic Musculoskeletal Diseases themes Other funding eg Manchester Academic Health Sciences and a recently awarded Medical Research Council Partnership grant will also support this programme The study will recruit in specialist NHS centres Recruitment will start in Manchester University Hospitals NHS Foundation Trust
Participants with IMID diagnoses will be recruited from rheumatologycardiology departments as in-patients or outpatients
Once consented researchers will collect past present and future clinical information about them including routine cardiovascular imaging and blood tests Participants will also be asked to complete questionnaires at predetermined intervals The participants could also be approached to take part in the following sub-studies Biological sub-study in which blood and urine would be collected And the Imaging-sub study in which one or more of Echocardiography Cardiovascular Magnetic Resonance Imaging CMR and Laser Doppler Imaging LDI will be performed Participants with CVD without IMID and healthy volunteers will also be recruited as comparison groups
The research is to be funded by the NIHR Manchester BRC Integrated Cardiovascular and Rheumatic Musculoskeletal Diseases themes Other funding eg Manchester Academic Health Sciences and a recently awarded Medical Research Council Partnership grant will also support this programme The study will recruit in specialist NHS centres Recruitment will start in Manchester University Hospitals NHS Foundation Trust
Detailed Description:
Immune-mediated-inflammatory-diseases IMID are a range of illnesses affecting over 1 million people in the UK
Targeted treatments have changed outcomes of common IMIDs but mortality is still high largely due to premature cardiovascular disease CVD IMID includes the common rheumatoid arthritis RA systemic lupus erythematosus SLE and related conditions and rare diseases such as systemic sclerosis SSc idiopathic inflammatory myopathies IIM and vasculitides Increased risk of CVD and death in IMID contributes to inflammation and cardio metabolic disorders which includes accelerated atherosclerosis microvascular dysfunction and myocardial and pericardial disease The research has shown people with RA have a 50 higher risk for CVD than the general population and up to 35 of deaths in patients with SSc are due to cardiac causes
The biological mechanisms underlying CVD in IMIDs remain largely unknown Two comparable IMID patients may have significant differences in the presence of CVD and the reasons for this are poorly understood Despite the significant morbidity and mortality associated with CVD in IMID patients identification of at-risk patients early in the disease to start treatments and improve prognosis remains challenging Difficulties also persist in tailoring treatments for people with IMID and existing CVD and there is an evidence gap in treating certain kind of cardiovascular involvement for example myocarditis This proposed study will address the missing gaps of the current knowledge The longitudinal collection and evaluation of routine clinical information and imaging data at different stages of disease will allow the researchers to develop a prognostic model to identify risk factors for CVD in IMID and identify at-risk IMID patients In addition the biological and imaging sub-studies will allow the researchers to gain comprehensive insights into the mechanisms underlying CVD in IMID patients including molecular pathways genetics and imaging biomarkers This programme of work will generate important pilot data that will inform subsequent definitive and fully powered studies
Any potentially eligible patients seen at the relevant rheumatologycardiology departments as part of in-patient outpatient andor multi-disciplinary team meetings and identified as per usual clinical practice may be eligible for inclusion in this observational programme these patients will be classified as IMID patients at-risk of CVD IMID-at risk CVD IMID patients with documented new major adverse cardiovascular event MACE Incident IMID-CVD and IMID patients with previous MACE Established IMID-CVD Three groups of control patients will also be recruited IMID patients with no risk of CVD patients with CVD but no IMID diagnosis and healthy volunteers
The doctor will explain to the patient about the study and if they are interested provide them with the information leaflet
The participant will have the opportunity to ask the research staff questions after they have seen the paperwork
Patients may consent same day andor be given the opportunity to discuss the trial with their family before they are asked whether they would be willing to take part in the trial If English is not the patients first language every effort will be made to provide a Trust interpreter according to normal Trust procedures This is an observational longitudinal study where past present and future routine clinical data and tests such as hospital presentations blood tests imaging andor additional sub-study specific research data will be collected and entered into a database Following consent data will be obtained as per usual clinical visits and assessments
Patients are seen as per standard clinical practice determined by the index IMID and in this setting also dependent on co-existing CV comorbidity This would usually be every 6 months at time of IMIDCVD diagnosis and then 12 monthly thereafter Following consent data from before this time point may be obtained through the available health records
Participants will also be asked to complete questionnaires determined by their IMID diagnosis andor CVD profile at follow up appointments These will be returned to the University of Manchester along with a registration form that will include confirmation of a participants contact information Patients will be given the opportunity to consent to the biological andor imaging sub-studies Unlike the main study participants will be asked to undergo biological tests blood tests or urine sample if applicable or imaging tests echocardiography cardiac magnetic resonance imaging peripheral imaging in addition to routine standard care
Where possible these additional tests will be combined with routine clinical care to minimise inconvenience to the participant for example collecting additional blood tests at same time of routine clinical blood test The additional imaging studies would need to be done on a separate visit to the routine clinical follow up
All procedures will be carried out by their local NHS clinical or research team at the Unit they are normally seen in MFT MRIWythenshawe site based on usual site of care and will be carried out by trained staff This is designed to fit around standard care as much as possible and provide as little inconvenience as possible to potential participants
All control subjects will be treated in the same way patient participants are The face-to-face consent process will be the same The research team will explain what is required of them what procedures they would be undertaking and the detail of these and where they would occur Patient-reported outcomes relevant to the IMID andor CVD profile may be taken at each visit if the participant consents to this These may include RAQoL HAQ EQ-5D ScleroID and clinician assessed New York Heart Association NYHA classification based on the patient history The research staff at the recruiting centre will access participants medical records where consent is provided for them to do so They will enter appropriate research data into an electronic case report form eCRF on the hospital site In the eCRF participants will be identified by study number only No personal identifiable information PII will be included in the eCRF
Targeted treatments have changed outcomes of common IMIDs but mortality is still high largely due to premature cardiovascular disease CVD IMID includes the common rheumatoid arthritis RA systemic lupus erythematosus SLE and related conditions and rare diseases such as systemic sclerosis SSc idiopathic inflammatory myopathies IIM and vasculitides Increased risk of CVD and death in IMID contributes to inflammation and cardio metabolic disorders which includes accelerated atherosclerosis microvascular dysfunction and myocardial and pericardial disease The research has shown people with RA have a 50 higher risk for CVD than the general population and up to 35 of deaths in patients with SSc are due to cardiac causes
The biological mechanisms underlying CVD in IMIDs remain largely unknown Two comparable IMID patients may have significant differences in the presence of CVD and the reasons for this are poorly understood Despite the significant morbidity and mortality associated with CVD in IMID patients identification of at-risk patients early in the disease to start treatments and improve prognosis remains challenging Difficulties also persist in tailoring treatments for people with IMID and existing CVD and there is an evidence gap in treating certain kind of cardiovascular involvement for example myocarditis This proposed study will address the missing gaps of the current knowledge The longitudinal collection and evaluation of routine clinical information and imaging data at different stages of disease will allow the researchers to develop a prognostic model to identify risk factors for CVD in IMID and identify at-risk IMID patients In addition the biological and imaging sub-studies will allow the researchers to gain comprehensive insights into the mechanisms underlying CVD in IMID patients including molecular pathways genetics and imaging biomarkers This programme of work will generate important pilot data that will inform subsequent definitive and fully powered studies
Any potentially eligible patients seen at the relevant rheumatologycardiology departments as part of in-patient outpatient andor multi-disciplinary team meetings and identified as per usual clinical practice may be eligible for inclusion in this observational programme these patients will be classified as IMID patients at-risk of CVD IMID-at risk CVD IMID patients with documented new major adverse cardiovascular event MACE Incident IMID-CVD and IMID patients with previous MACE Established IMID-CVD Three groups of control patients will also be recruited IMID patients with no risk of CVD patients with CVD but no IMID diagnosis and healthy volunteers
The doctor will explain to the patient about the study and if they are interested provide them with the information leaflet
The participant will have the opportunity to ask the research staff questions after they have seen the paperwork
Patients may consent same day andor be given the opportunity to discuss the trial with their family before they are asked whether they would be willing to take part in the trial If English is not the patients first language every effort will be made to provide a Trust interpreter according to normal Trust procedures This is an observational longitudinal study where past present and future routine clinical data and tests such as hospital presentations blood tests imaging andor additional sub-study specific research data will be collected and entered into a database Following consent data will be obtained as per usual clinical visits and assessments
Patients are seen as per standard clinical practice determined by the index IMID and in this setting also dependent on co-existing CV comorbidity This would usually be every 6 months at time of IMIDCVD diagnosis and then 12 monthly thereafter Following consent data from before this time point may be obtained through the available health records
Participants will also be asked to complete questionnaires determined by their IMID diagnosis andor CVD profile at follow up appointments These will be returned to the University of Manchester along with a registration form that will include confirmation of a participants contact information Patients will be given the opportunity to consent to the biological andor imaging sub-studies Unlike the main study participants will be asked to undergo biological tests blood tests or urine sample if applicable or imaging tests echocardiography cardiac magnetic resonance imaging peripheral imaging in addition to routine standard care
Where possible these additional tests will be combined with routine clinical care to minimise inconvenience to the participant for example collecting additional blood tests at same time of routine clinical blood test The additional imaging studies would need to be done on a separate visit to the routine clinical follow up
All procedures will be carried out by their local NHS clinical or research team at the Unit they are normally seen in MFT MRIWythenshawe site based on usual site of care and will be carried out by trained staff This is designed to fit around standard care as much as possible and provide as little inconvenience as possible to potential participants
All control subjects will be treated in the same way patient participants are The face-to-face consent process will be the same The research team will explain what is required of them what procedures they would be undertaking and the detail of these and where they would occur Patient-reported outcomes relevant to the IMID andor CVD profile may be taken at each visit if the participant consents to this These may include RAQoL HAQ EQ-5D ScleroID and clinician assessed New York Heart Association NYHA classification based on the patient history The research staff at the recruiting centre will access participants medical records where consent is provided for them to do so They will enter appropriate research data into an electronic case report form eCRF on the hospital site In the eCRF participants will be identified by study number only No personal identifiable information PII will be included in the eCRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None