Healthy VolunteersDECADENT-HVNCT05241184
Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers
An observational study of Healthy Volunteers, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Current MRI society guidelines recommend that reference ranges for specific imaging techniques (T1, T2 mapping, perfusion) are acquired on the MRI scanner that clinical work and research studies are being carried out on. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Multiparametric stress CMR protocol
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2021to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Adult, Older adult
Study population: Healthy volunteers aged at least 18 years with no prior medical history (including cardiovascular health problems, medication or systemic illness including COVID-19) will be invited to participate by i) contacting eligible participants from the Clinical research imaging volunteer bank ii) placing advertisements in public buildings (e.g. hospital, university). Vaccination status for SARS Coronavirus-19 is not an exclusion criterion. The other exclusion criteria include standard contraindications to MRI (e.g. metallic implants and metallic foreign body) and known or suspected pregnancy.
Who may be able to join
- Age 18≥years
- Capacity to provide written informed consent
- Able to comply with study procedures
- eGFR >45ml/min
- Vaccination status against SARS CoV-19 is not an exclusion criterion.
Who cannot join
- Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body.
- Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree AV block and sick sinus syndrome.
- Lack of informed consent.
- Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test
- History of cardiovascular illness.
- Previous COVID-19 illness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow, Lanarkshire, G51 4TF
Kenneth Mangion, MD PhD, 01412327600, kenneth.mangion@ggc.scot.nhs.uk
Robert Sykes, MBChB, 01412327600, robert.sykes@ggc.scot.nhs.uk
About this study
Current MRI society guidelines recommend that reference ranges for specific imaging techniques (T1, T2 mapping, perfusion) are acquired on the MRI scanner that clinical work and research studies are being carried out on. We propose to undertake 32 multi parametric stress cardiac MRI scans on healthy volunteers (50% female, 50% male) over the age of 18 years. These measurements are not yet available for the 3.0T Prisma scanner at the Institute of Clinical Excellence (ICE), Queen Elizabeth University Hospital (QEUH). These values are essential to identify what is abnormal for people living in the west of Scotland.
Read the detailed description
Imaging societies recommend that each MRI scanner has a locally-derived reference range for tissue characteristics, notably the longitudinal (T1) and transverse (T2) myocardial relaxation times, measured in milliseconds [16].
T1 reference values vary according to the magnetic field strength of the MRI scanner. T1 and T2 times (ms) are expectedly higher at 3.0T compared to 1.5T, in line with results obtained when working with the Siemens VERIO scanner based at the BHF Glasgow Cardiovascular Research Centre [17]. T2 values for 3.0T are, generally, not so well described and are known to vary between different manufacturers and systems.
A consensus statement by Society for Cardiovascular Magnetic Resonance (SCMR) endorsed by the European Association for Cardiovascular Imaging (EACVI) states that "Reference ranges should be generated from data sets that were acquired, processed, and analyzed in the same way as the intended application, with the upper and lower range of normal defined by the mean plus and minus 2 standard deviations of the normal data, respectively."[16] Myocardial blood flow measurements for both stress and rest are also distinct for individual scanners, especially at 3.0T. In fact, a number of centres have derived site specific and magnet specific reference ranges from healthy volunteers including 1)Stockholm, Sweden, 1.5T Siemens Avanto, 3.4 ± 0.7 ml/min/g [18] 2) Barts (London, UK) 3.0T Siemens Prisma, 3.00 +/-0.76 ml/g/min (unpublished data) and 3) Leeds, UK: 3.0T Siemens Prisma 2.89 ± 0.56 ml/g/min [19], 1.5T Philips Intera, 4.50 ± 0.91 ml/min/g[20] and studies are ongoing in sites such as Oxford (https://www.ouh.nhs.uk/research/patients/trials/stress-mri.aspx) . As can be seen, there is a wide spread of values and local reference ranges are urgently required (defined as stress MBF <2 standard deviations from the mean in healthy volunteers). These measurements are not yet available for the 3.0T Prisma scanner at the Institute of Clinical Excellence (ICE), Queen Elizabeth University Hospital (QEUH). These values are essential to identify what is abnormal for people living in the west of Scotland.
- Conditions
- Healthy Volunteers
- Being tested
- Multiparametric stress CMR protocol
- Keywords
- cardiovascular magnetic resonance imaging, adenosine stress, parametric mapping, reference ranges, strain, healthy volunteers
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric stress CMR protocolDiagnostic test
Multiparametric stress CMR protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak stress myocardial blood (mg/ml/min)
Peak stress myocardial blood with adenosine vasodilator stress
Measured: Through study completion, on average <2years.
Myocardial perfusion reserve
Myocardial perfusion reserve with adenosine vasodilator stress
Measured: Through study completion, on average <2years.
Global and septal T1 (MOLLI, shMOLLI) T2
reference ranges
Measured: Through study completion, on average <2years.
Global and regional Circumferential strain (GCS)
using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Measured: Through study completion, on average <2years.
Global and regional Longitudinal strain (GLS)
using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Measured: Through study completion, on average <2years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start10 Nov 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Kenneth Mangion, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241184
- Sponsor's protocol ID
- GN20CA408
- Acronym
- DECADENT-HV
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be on reasonable request to the CI
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05241184
- Acronym / sponsor ID
- DECADENT-HV / GN20CA408
- Conditions
- Healthy Volunteers
- Keywords
- cardiovascular magnetic resonance imaging, adenosine stress, parametric mapping, reference ranges, strain, healthy volunteers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 15 Feb 2022 (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.
Current MRI society guidelines recommend that reference ranges for specific imaging techniques (T1, T2 mapping, perfusion) are acquired on the MRI scanner that clinical work and research studies are being carried out on. We propose to undertake 32 multi parametric stress cardiac MRI scans on healthy volunteers (50% female, 50% male) over the age of 18 years. These measurements are not yet available for the 3.0T Prisma scanner at the Institute of Clinical Excellence (ICE), Queen Elizabeth University Hospital (QEUH). These values are essential to identify what is abnormal for people living in the west of Scotland.
Detailed description
Imaging societies recommend that each MRI scanner has a locally-derived reference range for tissue characteristics, notably the longitudinal (T1) and transverse (T2) myocardial relaxation times, measured in milliseconds [16].
T1 reference values vary according to the magnetic field strength of the MRI scanner. T1 and T2 times (ms) are expectedly higher at 3.0T compared to 1.5T, in line with results obtained when working with the Siemens VERIO scanner based at the BHF Glasgow Cardiovascular Research Centre [17]. T2 values for 3.0T are, generally, not so well described and are known to vary between different manufacturers and systems.
A consensus statement by Society for Cardiovascular Magnetic Resonance (SCMR) endorsed by the European Association for Cardiovascular Imaging (EACVI) states that "Reference ranges should be generated from data sets that were acquired, processed, and analyzed in the same way as the intended application, with the upper and lower range of normal defined by the mean plus and minus 2 standard deviations of the normal data, respectively."[16] Myocardial blood flow measurements for both stress and rest are also distinct for individual scanners, especially at 3.0T. In fact, a number of centres have derived site specific and magnet specific reference ranges from healthy volunteers including 1)Stockholm, Sweden, 1.5T Siemens Avanto, 3.4 ± 0.7 ml/min/g [18] 2) Barts (London, UK) 3.0T Siemens Prisma, 3.00 +/-0.76 ml/g/min (unpublished data) and 3) Leeds, UK: 3.0T Siemens Prisma 2.89 ± 0.56 ml/g/min [19], 1.5T Philips Intera, 4.50 ± 0.91 ml/min/g[20] and studies are ongoing in sites such as Oxford (https://www.ouh.nhs.uk/research/patients/trials/stress-mri.aspx) . As can be seen, there is a wide spread of values and local reference ranges are urgently required (defined as stress MBF <2 standard deviations from the mean in healthy volunteers). These measurements are not yet available for the 3.0T Prisma scanner at the Institute of Clinical Excellence (ICE), Queen Elizabeth University Hospital (QEUH). These values are essential to identify what is abnormal for people living in the west of Scotland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers aged at least 18 years with no prior medical history (including cardiovascular health problems, medication or systemic illness including COVID-19) will be invited to participate by i) contacting eligible participants from the Clinical research imaging volunteer bank ii) placing advertisements in public buildings (e.g. hospital, university). Vaccination status for SARS Coronavirus-19 is not an exclusion criterion. The other exclusion criteria include standard contraindications to MRI (e.g. metallic implants and metallic foreign body) and known or suspected pregnancy.
Key inclusion criteria (5 listed)
- Age 18≥years
- Capacity to provide written informed consent
- Able to comply with study procedures
- eGFR >45ml/min
- Vaccination status against SARS CoV-19 is not an exclusion criterion.
Key exclusion criteria (6 listed)
- Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body.
- Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree AV block and sick sinus syndrome.
- Lack of informed consent.
- Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test
- History of cardiovascular illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric stress CMR protocolMultiparametric stress CMR protocol | Diagnostic test | – |
Primary outcome
Peak stress myocardial blood (mg/ml/min)
Time frame: Through study completion, on average <2years.
Peak stress myocardial blood with adenosine vasodilator stress
Myocardial perfusion reserve
Time frame: Through study completion, on average <2years.
Myocardial perfusion reserve with adenosine vasodilator stress
Global and septal T1 (MOLLI, shMOLLI) T2
Time frame: Through study completion, on average <2years.
reference ranges
Global and regional Circumferential strain (GCS)
Time frame: Through study completion, on average <2years.
using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Global and regional Longitudinal strain (GLS)
Time frame: Through study completion, on average <2years.
using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Undecided. Data sharing will be on reasonable request to the CI
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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. This study is not recruiting at the moment.
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 Healthy Volunteers, run by University of Glasgow 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Mangion, MD PhD (0141 232 7600, kenneth.mangion@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak stress myocardial blood (mg/ml/min) (time frame: Through study completion, on average <2years.). The study lists 5 primary outcomes in all. 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 15 Feb 2022.