Cardiomyopathy, HypertrophicBikeMRINCT03040947
MRI Sequence and Imaging Protocol Development
An observational study of Cardiomyopathy, Hypertrophic and Cardiomyopathy, Dilated, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
The purpose of this study is to develop imaging protocols when using cardiovascular magnetic resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to support the numerous investigator initiated… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated, Left Ventricular Hypertrophy
- What is being tested?
- Cardiovascular Magnetic Resonance
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2016to Dec 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential participants will be identified from an existing database of healthy volunteers who had previously participated in the biobank program and indicated interest in future studies. Potential patients are identified from the imaging or admissions databases. The primary physicians of these patients identified will be notified prior to recruitment and the patient will only be recruited if the primary physician is agreeable. Alternatively, other methods of participant identification include co-workers of the department who volunteer themselves and indicate on the Informed Consent Document that their participation was entirely voluntary and not under coercion. Team members of this study are not eligible for participation.
Who may be able to join
- Has no known significant medical history
- Is able to give informed consent
Who cannot join
- Has contraindications to CMR implantable devices, cerebral aneutysm clips and cochlear implants
- Has claustrophobia
- Females who are pregnant
- Is unable to comply with study protocols
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Terrance Chua, MBBS, terrance.chua.s.j@singhealth.com.sg
Briana Ang, BSc, 6704 2298, briana.ang.w.y@nhcs.com.sg
About this study
The purpose of this study is to develop imaging protocols when using cardiovascular magnetic resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to support the numerous investigator initiated projects in patients with various cardiac pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be shortened for patients with underlying cardiac diseases.
Read the detailed description
In medical research, there is a continuous need to develop new imaging techniques such as cardiovascular magnetic resonance (CMR) imaging. This will allow us to visualize and study the function and structure of the heart in greater detail so as to improve the diagnosis and treatment of patients with various cardiac conditions. The aim of the study is to optimise new CMR sequences, allowing the development of imaging protocols in future research studies.
This study will hence recruit 800 subjects for each of the following sub-studies:
- Sub-study 1: Normal CMR protocols for assessment of cardiac function and morphology
- Sub-study 2: Exercise stress protocols with a CMR-compatible supine bike.
For the first sub-study, 400 healthy volunteers and patients with cardiac conditions or suspected to have cardiac conditions will be recruited. The testing and optimising of CMR sequence settings are crucial to ensure the accuracy and robustness of the scan before using the scan as a clinical diagnostic tool.
For the second sub-study, 400 healthy volunteers of different fitness levels and and patients with cardiac conditions or suspected to have cardiac conditions will be recruited. An exercise stress protocol will then be developed for future studies in patients with suspected coronary artery diseases. For this protocol, participants will be asked to cycle on a supine exercise bike to assess the effects of exercise and free breathing on the stability of the CMR imaging sequences.
- Conditions
- Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated, Left Ventricular Hypertrophy, Ischemic Heart Disease, Hypertension
- Being tested
- Cardiovascular Magnetic Resonance
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated, Hypertrophy, Left Ventricular, Myocardial Ischemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic ResonanceOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Healthy Volunteers will undergo a cardiovascular magnetic resonance imaging scan. Receives: Other: Cardiovascular Magnetic Resonance | |
| Diseased (Suspected or Known Cardiac Conditions) | Patients will undergo a cardiovascular magnetic resonance imaging scan. Receives: Other: Cardiovascular Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of cardiovascular event
This outcomes are obtained via hospital records or by a phone follow-up
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startMar 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiomyopathy, HypertrophicStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040947
- Sponsor's protocol ID
- 2016/2050
- Acronym
- BikeMRI
- Status last verified
- Jun 2020
- First submitted
- 31 Jan 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le TT, Bryant JA, Ting AE, Ho PY, Su B, Teo RC, Gan JS, Chung YC, O'Regan DP, Cook SA, Chin CW. Assessing exercise cardiac reserve using real-time cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2017 Jan 23;19(1):7. doi: 10.1186/s12968-017-0322-1.
PubMed 28110638
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Sequence and Imaging Protocol Development
- ClinicalTrials.gov ID
- NCT03040947
- Acronym / sponsor ID
- BikeMRI / 2016/2050
- Conditions
- Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated, Left Ventricular Hypertrophy, Ischemic Heart Disease, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- 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 purpose of this study is to develop imaging protocols when using cardiovascular magnetic resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to support the numerous investigator initiated projects in patients with various cardiac pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be shortened for patients with underlying cardiac diseases.
Detailed description
In medical research, there is a continuous need to develop new imaging techniques such as cardiovascular magnetic resonance (CMR) imaging. This will allow us to visualize and study the function and structure of the heart in greater detail so as to improve the diagnosis and treatment of patients with various cardiac conditions. The aim of the study is to optimise new CMR sequences, allowing the development of imaging protocols in future research studies.
This study will hence recruit 800 subjects for each of the following sub-studies:
- Sub-study 1: Normal CMR protocols for assessment of cardiac function and morphology
- Sub-study 2: Exercise stress protocols with a CMR-compatible supine bike.
For the first sub-study, 400 healthy volunteers and patients with cardiac conditions or suspected to have cardiac conditions will be recruited. The testing and optimising of CMR sequence settings are crucial to ensure the accuracy and robustness of the scan before using the scan as a clinical diagnostic tool.
For the second sub-study, 400 healthy volunteers of different fitness levels and and patients with cardiac conditions or suspected to have cardiac conditions will be recruited. An exercise stress protocol will then be developed for future studies in patients with suspected coronary artery diseases. For this protocol, participants will be asked to cycle on a supine exercise bike to assess the effects of exercise and free breathing on the stability of the CMR imaging sequences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Other: Cardiovascular Magnetic ResonanceHealthy Volunteers will undergo a cardiovascular magnetic resonance imaging scan. |
| Diseased (Suspected or Known Cardiac Conditions) | – | Other: Cardiovascular Magnetic ResonancePatients will undergo a cardiovascular magnetic resonance imaging scan. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be identified from an existing database of healthy volunteers who had previously participated in the biobank program and indicated interest in future studies. Potential patients are identified from the imaging or admissions databases. The primary physicians of these patients identified will be notified prior to recruitment and the patient will only be recruited if the primary physician is agreeable. Alternatively, other methods of participant identification include co-workers of the department who volunteer themselves and indicate on the Informed Consent Document that their participation was entirely voluntary and not under coercion. Team members of this study are not eligible for participation.
Key inclusion criteria (2 listed)
- Has no known significant medical history
- Is able to give informed consent
Key exclusion criteria (4 listed)
- Has contraindications to CMR implantable devices, cerebral aneutysm clips and cochlear implants
- Has claustrophobia
- Females who are pregnant
- Is unable to comply with study protocols
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 |
|---|---|---|
| Cardiovascular Magnetic Resonance | Other | Diseased (Suspected or Known Cardiac Conditions), Healthy Volunteer |
Primary outcome
First occurrence of cardiovascular event
Time frame: 1 day
This outcomes are obtained via hospital records or by a phone follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Results publication: PubMed 28110638Le TT, Bryant JA, Ting AE, Ho PY, Su B, Teo RC, Gan JS, Chung YC, O'Regan DP, Cook SA, Chin CW. Assessing exercise cardiac reserve using real-time cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2017 Jan 23;19(1):7. doi: 10.1186/s12968-017-0322-1.
- Individual participant dataSharing planned: No
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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. 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 Cardiomyopathy, Hypertrophic and Cardiomyopathy, Dilated, run by National Heart Centre Singapore at 1 site in Singapore.
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 2 inclusion and 4 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 3 Mar 2021. 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 Singapore. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First occurrence of cardiovascular event (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040947, which also lists 1 linked publication.
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 3 Mar 2021.