Cardiovascular DiseasesGM CARDIO-IMIDNCT06600737
Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
An observational study of Cardiovascular Diseases and Rheumatologic Disease, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Rheumatologic Disease
- Type of treatment
- Vaccines
- How many people
- 325 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2024to 1 Sep 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from NHS secondary care in the United Kingdom. Potential participants may be identified from clinics, wards, diagnostic pathways and departments, electronic and paper-based health records, databases and waiting lists in secondary care. All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
Who may be able to join
- 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.
Show all 13Show fewer
- Established IMID-CVD: Patients with IMID and a history of previous MACE
- As-listed for Main Study
- As-listed for Main Study
- 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)
Who cannot join
- Age less than 18 years
- Lack of capacity to give informed consent
- Imaging Sub-Study
- 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
Show all 12Show fewer
- As-listed for Main Study
- Controls
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maya H Buch, MD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
Abbie Edwards, abbie.edwards@mft.nhs.uk
Maya H Buch, PhD
About this study
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 rheumatology/cardiology departments as in-patients or outpatients.
Read more
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.
Read the 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 rheumatology/cardiology departments as part of in-patient, outpatient and/or 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 and/or 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 patient's 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) and/or 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 IMID/CVD 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 and/or 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 participant's contact information. Patients will be given the opportunity to consent to the biological and/or 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 (MRI/Wythenshawe 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 and/or 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 participant's 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.
- Conditions
- Cardiovascular Diseases, Rheumatologic Disease
- Medical subject headings
- Cardiovascular Diseases, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Disease Control (IMID and no CV disease) | Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also. Where indicated, two groups of disease control patients will be recruited: (i) patients with an IMID and no CV disease and (ii) patients with CVD and no IMID diagnosis. The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires | |
| Disease Control (CV disease and no IMID) | Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also. Where indicated, two groups of disease control patients will be recruited: (i) patients with an IMID and no CV disease and (ii) patients with CVD and no IMID diagnosis. The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires | |
| Healthy Control (no IMID history or CV disease) | Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also. Healthy Control participants will have a limited number of assessments performed which may include: * Demographics, employment * Medical history, diagnoses, co-morbidities, symptoms, signs, lifestyle (smoking status (pack years) and alcohol intake (units/week), CVD risk scores * Detailed family history of autoimmune, vascular and rheumatic disease * Medications, vaccinations * Physical status (e.g. height and weight, blood pressure), IMID disease activity assessment as indicated * Data on hospital attendances and admissions, MACE, death registry information. | |
| Main Study (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). The main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD). The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires | |
| Main Study (Incident (new) IMID-CVD) | Patients with IMID that present with a MACE. The main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD). The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires | |
| Main Study (Established IMID-CVD) | Patients with IMID and a history of previous MACE. The main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD). The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires | |
| Imaging Sub-Study | In addition to the main study, patients will be offered the opportunity to consent to participate in the imaging Sub-Study. Patients consenting to the Imaging Sub-Study must also have consented to participate in the Main Study. Assessments conducted as part of the Main Study are outlined in the relevant 'Main Study' Group/Cohort descriptions. Individuals participating in the Imaging Sub-Study may be asked to undergo additional imaging tests above standard of care (undertaken separately to the main study assessments/visits) using dedicated research protocols. The following assessments may be conducted: Echocardiography Cardiovascular Magnetic Resonance Imaging (CMR) Peripheral vascular imaging techniques: Laser Doppler Imaging (LDI) and laser speckle contrast imaging (LSCI) Nailfold capillaroscopy Multispectral imaging Non-vascular skin imaging techniques: High frequency ultrasound | |
| Biological Sub-Study | In addition to the Main Study, patients will be offered the opportunity to consent to participate in the Biological Sub-Study. Patients consenting to the Biological Sub-Study must also have consented to participate in the Main Study. Assessments conducted as part of the Main Study are outlined in the relevant 'Main Study' Group/Cohort descriptions. Biological samples as part of the Sub-Study are in addition to standard of care blood samples. A maximum of 75mls of blood may be taken to enable the range of experimental studies. The samples may be taken at initial time of recruitment (baseline) and/or may be repeated at certain time points depending on the diagnosis and if a change in the clinical status (excluding genotyping). The blood may be drawn into a combination of EDTA, lithium heparin, red clotted, citrate and PAXGENE/TEMPUS tubes, according to planned experiments at each time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major adverse cardiovascular events (MACE)
Major Adverse Cardiovascular Events (MACE) is a grouped term typically defined as acute myocardial infarction, stroke or cardiovascular death. Primary myocardial events such as myocarditis (especially relevant to IMIDs such as SSc, IIM, SLE) will also form part of the primary MACE definition.
The total number of participants presenting with or developing a MACE will be measured.
Unit: number of participants
Measured: 10 Years
Secondary outcomes (7)
Number of participants with heart failure hospitalisations
Extended MACE endpoints that may comprise all ischaemic CV events/significant clinical outcomes will also be captured: Heart failure hospitalisation, unstable angina, need for revascularisation, all-cause mortality.
The total number of participants hospitalised with heart failure will be measured.
Unit: number of participants
Measured: 10 Years
Number of participants with unstable angina
Extended MACE endpoints that may comprise all ischaemic CV events/significant clinical outcomes will also be captured: Heart failure hospitalisation, unstable angina, need for revascularisation, all-cause mortality.
The total number of participants with unstable angina will be measured.
Unit: number of participants
Measured: 10 Years
Number of participants needing revascularisation
Extended MACE endpoints that may comprise all ischaemic CV events/significant clinical outcomes will also be captured: Heart failure hospitalisation, unstable angina, need for revascularisation, all-cause mortality.
The total number of participants needing revascularisation will be measured.
Unit: number of participants
Measured: 10 Years
Number of participants with abnormal high-sensitivity cardiac troponin I/T levels
The total number of participants with abnormal high-sensitivity troponin I/T levels (assessed by blood draw) will be measured.
Unit: number of participants
Measured: 10 Years
Number of participants with abnormal ECHO and or CMR imaging measures
ECHO and or CMR imaging measures include atrial and ventricular volumetrics, systolic and diastolic function, regional wall motion abnormalities, myocardial inflammation (CMR only), presence and extent of replacement fibrosis (CMR only), aortic distensibility (CMR only).
The total number of participants with abnormal ECHO and/or CMR imaging measures will be measured.
Unit: number of participants
Measured: 10 Years
Number of participants with abnormal N-terminal pro B-type natriuretic peptide (NT-pro BNP) levels
The total number of participants with abnormal NT-pro BNP levels (assessed by blood draw) will be measured.
Unit: number of participants
Measured: 10 Years
Number of participants with abnormal Creatine Kinase (CK) levels
The total number of participants with abnormal Creatine Kinase levels (assessed by blood draw) will be measured.
Unit: number of participants
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion1 Sep 2032 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maya H. Buch, University of Manchester
- Investigators
- Maya H Buch, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600737
- Sponsor's protocol ID
- 320989
- Acronym
- GM CARDIO-IMID
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT06600737
- Acronym / sponsor ID
- GM CARDIO-IMID / 320989
- Conditions
- Cardiovascular Diseases, Rheumatologic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2032 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 rheumatology/cardiology 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 rheumatology/cardiology departments as part of in-patient, outpatient and/or 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 and/or 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 patient's 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) and/or 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 IMID/CVD 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 and/or 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 participant's contact information. Patients will be given the opportunity to consent to the biological and/or 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 (MRI/Wythenshawe 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 and/or 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 participant's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Disease Control (IMID and no CV disease) | – | –Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also. Where indicated, two groups of disease control patients will be recruited: (i) patients with an IMID and no CV disease and (ii) patients with CVD and no IMID diagnosis. The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires |
| Disease Control (CV disease and no IMID) | – | –Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also. Where indicated, two groups of disease control patients will be recruited: (i) patients with an IMID and no CV disease and (ii) patients with CVD and no IMID diagnosis. The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires |
| Healthy Control (no IMID history or CV disease) | – | –Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also. Healthy Control participants will have a limited number of assessments performed which may include: * Demographics, employment * Medical history, diagnoses, co-morbidities, symptoms, signs, lifestyle (smoking status (pack years) and alcohol intake (units/week), CVD risk scores * Detailed family history of autoimmune, vascular and rheumatic disease * Medications, vaccinations * Physical status (e.g. height and weight, blood pressure), IMID disease activity assessment as indicated * Data on hospital attendances and admissions, MACE, death registry information. |
| Main Study (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). The main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD). The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires |
| Main Study (Incident (new) IMID-CVD) | – | –Patients with IMID that present with a MACE. The main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD). The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires |
| Main Study (Established IMID-CVD) | – | –Patients with IMID and a history of previous MACE. The main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD). The following assessments will be conducted (if indicated as part of a participants standard care): Clinician Questionnaires Clinical/medical, health and social care and social determinants Routine laboratory assessments Routine cardiovascular imaging and electrophysiology assessments Investigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care Routine peripheral vascular imaging assessment Patient reported outcome measures (PROMs) Questionnaires |
| Imaging Sub-Study | – | –In addition to the main study, patients will be offered the opportunity to consent to participate in the imaging Sub-Study. Patients consenting to the Imaging Sub-Study must also have consented to participate in the Main Study. Assessments conducted as part of the Main Study are outlined in the relevant 'Main Study' Group/Cohort descriptions. Individuals participating in the Imaging Sub-Study may be asked to undergo additional imaging tests above standard of care (undertaken separately to the main study assessments/visits) using dedicated research protocols. The following assessments may be conducted: Echocardiography Cardiovascular Magnetic Resonance Imaging (CMR) Peripheral vascular imaging techniques: Laser Doppler Imaging (LDI) and laser speckle contrast imaging (LSCI) Nailfold capillaroscopy Multispectral imaging Non-vascular skin imaging techniques: High frequency ultrasound |
| Biological Sub-Study | – | –In addition to the Main Study, patients will be offered the opportunity to consent to participate in the Biological Sub-Study. Patients consenting to the Biological Sub-Study must also have consented to participate in the Main Study. Assessments conducted as part of the Main Study are outlined in the relevant 'Main Study' Group/Cohort descriptions. Biological samples as part of the Sub-Study are in addition to standard of care blood samples. A maximum of 75mls of blood may be taken to enable the range of experimental studies. The samples may be taken at initial time of recruitment (baseline) and/or may be repeated at certain time points depending on the diagnosis and if a change in the clinical status (excluding genotyping). The blood may be drawn into a combination of EDTA, lithium heparin, red clotted, citrate and PAXGENE/TEMPUS tubes, according to planned experiments at each time point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from NHS secondary care in the United Kingdom. Potential participants may be identified from clinics, wards, diagnostic pathways and departments, electronic and paper-based health records, databases and waiting lists in secondary care. All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (12 listed)
- Age less than 18 years
- Lack of capacity to give informed consent
- Imaging Sub-Study
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with major adverse cardiovascular events (MACE)
Time frame: 10 Years
Major Adverse Cardiovascular Events (MACE) is a grouped term typically defined as acute myocardial infarction, stroke or cardiovascular death. Primary myocardial events such as myocarditis (especially relevant to IMIDs such as SSc, IIM, SLE) will also form part of the primary MACE definition. The total number of participants presenting with or developing a MACE will be measured. Unit: number of participants
7 secondary outcomes
Number of participants with heart failure hospitalisations
Time frame: 10 Years
Number of participants with unstable angina
Time frame: 10 Years
Number of participants needing revascularisation
Time frame: 10 Years
Number of participants with abnormal high-sensitivity cardiac troponin I/T levels
Time frame: 10 Years
Number of participants with abnormal ECHO and or CMR imaging measures
Time frame: 10 Years
Number of participants with abnormal N-terminal pro B-type natriuretic peptide (NT-pro BNP) levels
Time frame: 10 Years
Number of participants with abnormal Creatine Kinase (CK) levels
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya H Buch, MD contact
Maya H Buch, MD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Rheumatologic Disease, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Lawrence, MSc (+44 161 306 5679, james.lawrence@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major adverse cardiovascular events (MACE) (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.