Coronary Artery StenosisiNav-AUTO CMRANCT05473117
iNav-based, Automated Coronary Magnetic Resonance Angiography for the Detection of Coronary Artery Stenosis
An observational study of Coronary Artery Stenosis, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- Coronary Magnetic Resonance Angiography (CMRA)
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- ≥18 years old
- Subject has provided informed written consent
- BMI < 35
- Sinus Rhythm
- Stable symptom at time of inclusion
- Undergoing CCTA within 28 days
Who cannot join
- Any contraindication to CMR
- Previous coronary revascularisation
- Inability to take sublingual nitroglycerin
- Irregular heart rate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aarhus University Hospital
Aarhus, 8200
Gregory Wood, +45 40 14 04 21, gregory.wood@clin.au.dk
Alexandra Pedersen, +45 40 14 04 21, aup@clin.au.dk
About this study
Official title: 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.
Read more
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.
- Conditions
- Coronary Artery Stenosis
- Being tested
- Coronary Magnetic Resonance Angiography (CMRA)
- Keywords
- Coronary Magnetic Resonance Angiography, Coronary Artery Stenosis, Artificial Intelligence
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Magnetic Resonance Angiography (CMRA)Diagnostic test
A highly optimised CMRA protocol integrating advanced, automated software for detection of coronary artery stenosis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Coronary Magnetic Resonance Angiography (CMRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamically significant CAD
Number of patients with haemodynamically significant CAD, defined as coronary artery diameter stenosis ≥50%, as assessed by CMRA, compared to CCTA.
Measured: 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
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Wood, University of Aarhus
- Investigators
- Won Yong Kim, Study chair, Department of Cardiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473117
- Sponsor's protocol ID
- iNav-AUTO CMRA
- Acronym
- iNav-AUTO CMRA
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39293786
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iNav-based, Automated Coronary Magnetic Resonance Angiography for the Detection of Coronary Artery Stenosis (iNav-AUTO CMRA)
- ClinicalTrials.gov ID
- NCT05473117
- Acronym / sponsor ID
- iNav-AUTO CMRA / iNav-AUTO CMRA
- Conditions
- Coronary Artery Stenosis
- Keywords
- Coronary Magnetic Resonance Angiography, Coronary Artery Stenosis, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Diagnostic Test: Coronary Magnetic Resonance Angiography (CMRA)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- ≥18 years old
- Subject has provided informed written consent
- BMI < 35
- Sinus Rhythm
- Stable symptom at time of inclusion
Key exclusion criteria (4 listed)
- Any contraindication to CMR
- Previous coronary revascularisation
- Inability to take sublingual nitroglycerin
- Irregular heart rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Magnetic Resonance Angiography (CMRA)A highly optimised CMRA protocol integrating advanced, automated software for detection of coronary artery stenosis | Diagnostic test | Patient Group |
Primary outcome
Haemodynamically significant CAD
Time frame: 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.
Number of patients with haemodynamically significant CAD, defined as coronary artery diameter stenosis ≥50%, as assessed by CMRA, compared to CCTA.
1 secondary outcome
Image quality
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 39293786Wood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Won Yong Kim study chair
Department of Cardiology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Stenosis, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Wood (+45 40 14 04 21, gregory.wood@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamically significant CAD (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.