MRI Sequence and Imaging Protocol Development

NCT ID: NCT03040947

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Cardiomyopathy, Hypertrophic Cardiomyopathy, Dilated Left Ventricular Hypertrophy Ischemic Heart Disease Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteer

Healthy Volunteers will undergo a cardiovascular magnetic resonance imaging scan.

Cardiovascular Magnetic Resonance

Intervention Type OTHER

Diseased (Suspected or Known Cardiac Conditions)

Patients will undergo a cardiovascular magnetic resonance imaging scan.

Cardiovascular Magnetic Resonance

Intervention Type OTHER

Interventions

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Cardiovascular Magnetic Resonance

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Heart Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Facility Contacts

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Terrance Chua, MBBS

Role: primary

Briana Ang, BSc

Role: backup

6704 2298

References

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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.

Reference Type RESULT
PMID: 28110638 (View on PubMed)

Other Identifiers

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2016/2050

Identifier Type: -

Identifier Source: org_study_id

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