BikeMRI: MRI Sequence and Imaging Protocol Development

Sponsor

National Heart Centre Singapore (Other)

Overall Status

Recruiting

CT.gov ID

NCT03040947

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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:

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

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

MRI Sequence and Imaging Protocol Development

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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