- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040947
MRI Sequence and Imaging Protocol Development (BikeMRI)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 169609
- Recruiting
- National Heart Centre Singapore
-
Contact:
- Briana Ang, BSc
- Phone Number: 6704 2298
- Email: briana.ang.w.y@nhcs.com.sg
-
Contact:
- Terrance Chua, MBBS
- Email: terrance.chua.s.j@singhealth.com.sg
-
Principal Investigator:
- Calvin Chin, MBBS, PhD
-
Sub-Investigator:
- Le Thu Thao, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- Has no known significant medical history
- Is able to give informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Volunteer
Healthy Volunteers will undergo a cardiovascular magnetic resonance imaging scan.
|
|
Diseased (Suspected or Known Cardiac Conditions)
Patients will undergo a cardiovascular magnetic resonance imaging scan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
First occurrence of cardiovascular event
Time Frame: 1 day
|
This outcomes are obtained via hospital records or by a phone follow-up
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Genetic Diseases, Inborn
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Coronary Disease
- Cardiomegaly
- Laminopathies
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Hypertrophy
- Cardiomyopathies
- Cardiomyopathy, Dilated
- Cardiomyopathy, Hypertrophic
- Hypertrophy, Left Ventricular
Other Study ID Numbers
- 2016/2050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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