iNav-based, Automated Coronary Magnetic Resonance Angiography for the Detection of Coronary Artery Stenosis
iNav-AUTO CMRA
1 other identifier
observational
160
1 country
1
Brief Summary
Ischaemic Heart Disease (IHD) is the worlds leading cause of death. IHD is often caused by a narrowing of the coronary arteries, which prevents blood from flowing to the heart muscle, causing pain and damage to the heart. If an individual has a myocardial infarction (MI), parts of the heart that are damaged cannot be repaired. Therefore, it is important to identify and treat the narrowing of the arteries before an MI occurs. At present there are 2 main methods of identifying narrowing of the arteries. The first is an invasive procedure, the other using a CT scan. Whilst both methods are effective, they entail risk. The invasive procedure can damage the coronary arteries, whilst the CT scan exposes patients to radiation and contrast, which can increase the risk of cancer and allergic reactions. Magnetic Resonance (MR) scanning is an alternative to these methods, but it has been limited in use in the past due, in part, to the high technical knowledge required to obtain images. In addition, there is a degree of subjectivity in the selection of the mid-diastolic rest period, potentially affecting consistency of results. This means it is difficult to use in a day-to-day hospital environment. However, recent technological developments using artificial intelligence mean that images can be acquired in a more automated and consistent fashion. This new scan has yet to be tested in a clinical trial. Therefore, the objective of the clinical study is to test this new scan to determine its efficacy. 230 patients at 5 sites at risk of coronary artery disease, who have been referred for invasive coronary angiography, will undergo both their angiography and the new MR scan. The MR scan will then be compared to CCTA for diagnostic accuracy and image quality. The investigators hypothesise that the new MR scan will have the same diagnostic accuracy as invasive coronary angiography, with no differences in interpretation of the images across the 5 different hospitals. If proven effective, this would demonstrate that MR scanning of the coronary arteries could prove a safe, clinically useful alternative to both CT scanning and invasive assessment of coronary artery narrowing. In addition, if there is no difference across different locations, it would demonstrate that these scans can be performed consistently, facilitating implementation on a healthcare-system wide basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJune 22, 2023
June 1, 2023
1.5 years
July 19, 2022
June 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Haemodynamically significant CAD
Number of patients with haemodynamically significant CAD, defined as coronary artery diameter stenosis ≥50%, as assessed by CMRA, compared to CCTA.
CCTA will take place on clinical indication to investigate risk of CAD following an episode of chest pain. CMRA will be acquired ± 4 weeks compared to CCTA.
Secondary Outcomes (1)
Image quality
CCTA will take place on clinical indication to investigate risk of CAD following an episode of chest pain. CMRA will be acquired ± 4 weeks compared to CCTA.
Other Outcomes (2)
Inter-reader variability in interpretation of the CMRA protocol
CCTA will take place on clinical indication to investigate risk of CAD following an episode of chest pain. CMRA will be acquired ± 4 weeks compared to CCTA.
Pulse rate
CCTA will take place on clinical indication to investigate risk of CAD following an episode of chest pain. CMRA will be acquired ± 4 weeks compared to CCTA.
Study Arms (1)
Patient Group
A single cohort consisting of 230 patients referred for CT Coronary Angiography (CCTA) at risk of coronary artery disease. All patients will undergo both CCTA and CMRA
Interventions
A highly optimised CMRA protocol integrating advanced, automated software for detection of coronary artery stenosis
Eligibility Criteria
The study population will be drawn from individuals referred to CCTA for assessment of the coronary arteries living in the regions of the 5 study sites, which are based at the following hospitals: * Aarhus University Hospital (Aarhus, Denmark) * Herlev-Gentofte Hospital (Copenhagen, Denmark) * Kings College London (London, UK) * Hammersmith Hospital (London, UK) * Rigshospitalet (Copenhagen, Denmark)
You may qualify if:
- ≥18 years old
- Subject has provided informed written consent
- BMI \< 35
- Sinus Rhythm
- Undergoing CCTA within 28 days
You may not qualify if:
- Any contraindication to CMR
- Previous coronary revascularisation
- Inability to take sublingual nitroglycerin
- Irregular heart rate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, 8200, Denmark
Related Publications (1)
Wood G, Hajhosseiny R, Pedersen AU, Littlewood S, Hansen TJ, Neji R, Kunze KP, Wetzl J, Norgaard BL, Jensen JM, Maeng M, Madsen PL, Vejlstrup N, Prieto C, Botnar RM, Kim WY. Image navigator-based, automated coronary magnetic resonance angiography for the detection of coronary artery stenosis. J Cardiovasc Magn Reson. 2024 Winter;26(2):101097. doi: 10.1016/j.jocmr.2024.101097. Epub 2024 Sep 16.
PMID: 39293786DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Won Yong Kim
Department of Cardiology, Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 25, 2022
Study Start
June 1, 2024
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
June 22, 2023
Record last verified: 2023-06