MRI Sequence and Imaging Protocol Development

Hypertension Clinical Trial

— BikeMRI  

Official title:

MRI Sequence and Imaging Protocol Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03040947
• Other study ID #: 2016/2050
• Status: Recruiting
• Start date: March 2016
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: National Heart Centre Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Coronary Artery Disease
• Heart Diseases
• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular
• Ischemic Heart Disease
• Left Ventricular Hypertrophy
• Myocardial Ischemia

Intervention

Other:
• Cardiovascular Magnetic Resonance

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Centre Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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/s12968-017-032 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First occurrence of cardiovascular event	This outcomes are obtained via hospital records or by a phone follow-up	1 day