MRI Sequence and Imaging Protocol Development

• Conditions: Cardiomyopathy, Hypertrophic; Hypertension; Cardiomyopathy, Dilated; Left Ventricular Hypertrophy; Ischemic Heart Disease
• Interventions: Other: Cardiovascular Magnetic Resonance

• Registration Number: NCT03040947
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Status Verified: 2020-06
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
First occurrence of cardiovascular event	1 day	This outcomes are obtained via hospital records or by a phone follow-up

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore