iNav-based, Automated Coronary Magnetic Resonance Angiography for the Detection of Coronary Artery Stenosis (iNav-AUTO CMRA)

iNav-based, Automated Coronary Magnetic Resonance Angiography for the Detection of Coronary Artery Stenosis (iNav-AUTO CMRA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Stenosis
• Intervention / Treatment: Diagnostic test: Coronary Magnetic Resonance Angiography (CMRA)

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Gregory Wood; Phone Number: +45 40 14 04 21; Email: gregory.wood@clin.au.dk
• Study Contact Backup: Name: Alexandra Pedersen; Phone Number: +45 40 14 04 21; Email: alxped@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
    • Contact: Gregory Wood; Phone Number: +45 40 14 04 21; Email: gregory.wood@clin.au.dk
    • Contact: Alexandra Pedersen; Phone Number: +45 40 14 04 21; Email: aup@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

Inclusion Criteria:

• Inclusion Criteria:
• ≥18 years old
• Subject has provided informed written consent
• BMI < 35
• Sinus Rhythm
• Stable symptom at time of inclusion
• Undergoing CCTA within 28 days

Exclusion Criteria:

• Any contraindication to CMR
• Previous coronary revascularisation
• Inability to take sublingual nitroglycerin
• Irregular heart rate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Coronary Magnetic Resonance Angiography (CMRA); A highly optimised CMRA protocol integrating advanced, automated software for detection of coronary artery stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality	Qualitative assessment of the image quality of the CMRA images. The scale used will be: 0, non-diagnostic; 1, poor (limited coronary vessel visibility or noisy image); 2, average (coronary vessel visible but diagnostic confidence low); 3, good (coronary artery adequately visualised and diagnostic quality image); and 4, excellent (coronary artery clearly depicted).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-reader variability in interpretation of the CMRA protocol	Number of patients with haemodynamically significant CAD, defined as coronary artery diameter stenosis ≥50%, as assessed by CMRA, as compared between different investigators at different sites in the multi-centre study.	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	Pulse during CMRA scan acquisition and association with image quality metrics	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.

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Study Chair: Won Yong Kim, Department of Cardiology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Coronary Artery Stenosis; Coronary Magnetic Resonance Angiography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: iNav-AUTO CMRA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No