iNav-based, Automated Coronary Magnetic Resonance Angiography for the Detection of Coronary Artery Stenosis

Coronary Artery Stenosis Clinical Trial

— iNav-AUTO CMRA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05473117
• Other study ID #: iNav-AUTO CMRA
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Aarhus University Hospital
• Contact: Gregory Wood
• Phone: +45 40 14 04 21
• Email: gregory.wood[@]clin.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Diagnostic Test:
• Coronary Magnetic Resonance Angiography (CMRA)
A highly optimised CMRA protocol integrating advanced, automated software for detection of coronary artery stenosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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	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.