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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Effectiveness of Coronary Magnetic Resonance Angiography (CMRA) Imaging

NCT00001633

Coronary Disease

COMPLETED PHASE2

Intracoronary Thrombus Detection by Magnetic Resonance Imaging

NCT02776657

Angina Pectoris Angina, Stable Angina, Unstable +1 more

COMPLETED NA

International Study of Artificial Intelligence-based Diagnosis of Cardiomyopathy Using Cardiac MRI (AID-MRI)

NCT05793840

Cardiomyopathies

ENROLLING_BY_INVITATION

Characterization of Irreversible Myocardial Injury in Cardiomyopathies by Contrast-enhanced CMR

NCT00549861

Cardiomyopathy, Dilated Cardiomyopathies, Secondary

COMPLETED NA

Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention

NCT02580851

Stable Coronary Artery Disease Cardiac Magnetic Resonance Imaging Coronary Angiography +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Coronary Magnetic Resonance Angiography (CMRA)

Intervention Type DIAGNOSTIC_TEST

A highly optimised CMRA protocol integrating advanced, automated software for detection of coronary artery stenosis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coronary Magnetic Resonance Angiography (CMRA)

A highly optimised CMRA protocol integrating advanced, automated software for detection of coronary artery stenosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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