Clinical trial NCT03040947: MRI Sequence and Imaging Protocol Development
Official title: MRI Sequence and Imaging Protocol Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Left Ventricular Hypertrophy
Ischemic Heart Disease
Hypertension
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: First occurrence of cardiovascular event
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
References:
citation: 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.