MRI Sequence and Imaging Protocol Development (BikeMRI)

March 2, 2021 updated by: National Heart Centre Singapore
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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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