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MRI Sequence and Imaging Protocol Development (BikeMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040947
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Heart Centre Singapore

Brief 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 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.

Condition or disease Intervention/treatment
Cardiomyopathy, Hypertrophic Cardiomyopathy, Dilated Left Ventricular Hypertrophy Ischemic Heart Disease Hypertension Other: Cardiovascular Magnetic Resonance

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:

  1. Sub-study 1: Normal CMR protocols for assessment of cardiac function and morphology
  2. 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI Sequence and Imaging Protocol Development
Study Start Date : March 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


Group/Cohort Intervention/treatment
Healthy Volunteer
Healthy Volunteers will undergo a cardiovascular magnetic resonance imaging scan.
Other: Cardiovascular Magnetic Resonance
Diseased (Suspected or Known Cardiac Conditions)
Patients will undergo a cardiovascular magnetic resonance imaging scan.
Other: Cardiovascular Magnetic Resonance



Primary Outcome Measures :
  1. First occurrence of cardiovascular event [ Time Frame: 1 day ]
    This outcomes are obtained via hospital records or by a phone follow-up


Biospecimen Retention:   Samples With DNA
Blood samples will be collected from all participants before and after the CMR scan.


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040947


Locations
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Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Contact: Terrance Chua, MBBS       terrance.chua.s.j@singhealth.com.sg   
Contact: Briana Ang, BSc    6704 2298    briana.ang.w.y@nhcs.com.sg   
Principal Investigator: Calvin Chin, MBBS, PhD         
Sub-Investigator: Le Thu Thao, PhD         
Sponsors and Collaborators
National Heart Centre Singapore
Publications of Results:
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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT03040947    
Other Study ID Numbers: 2016/2050
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Hypertrophy, Left Ventricular
Cardiomyopathy, Dilated
Cardiomyopathy, Hypertrophic
Hypertrophy
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Cardiomegaly
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases