Angina, Stable(AI)NOCANCT06387693
Artificial Intelligence in ANOCA
A study testing Holter monitoring, intracoronary ECG in people with Angina, Stable, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Angina pectoris is diagnosed in >180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Stable
- What is being tested?
- Holter monitoring, intracoronary ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Dec 2024to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Clinical indication for comprehensive coronary function testing because of persisting chest discomfort at least 2 times per week despite current medical therapy.
- Absence of obstructive coronary artery disease with an indication for revascularization, documented by means of recent coronary computed tomography angiography (CCTA) or invasive coronary angiography (with invasive coronary pressure measurements if clinically indicated).
- Patient is willing and able to provide written informed consent.
Who cannot join
- Absence of chest discomfort after initiation of medical therapy.
- Language barrier preventing sufficient understanding and communication in Dutch.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Tim P. van de Hoef, M.D., Ph.D., 0031887555555, t.p.vandehoef@umcutrecht.nl
About this study
Official title: Artificial Intelligence-assisted Diagnostics In Angina With No Obstructive Coronary Artery Disease
Angina pectoris is diagnosed in >180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.
The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.
During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA.
- Conditions
- Angina, Stable
- Being tested
- Holter monitoring, intracoronary ECG
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter monitoring, intracoronary ECGDiagnostic test
Holter monitoring device to track ECG abnormalities during spontaneous chest pain in the outpatient setting. Intracoronary ECG to evaluate perprocedural ECG responses
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Intracoronary ECG and Holter ECG monitoring Receives: Diagnostic Test: Holter monitoring, intracoronary ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myocardial ischemia in patients with equivocal coronary function test results
The prevalence of ischemic changes on the intracoronary ECG in patients with equivocal coronary function test results.
Measured: During the procedure
Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders
Accuracy of the Holter ECG to identify ischemic ECG changes compared with the standard 12-lead ECG during acetylcholine-provoked chest pain.
Measured: During the procedure
Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders
Diagnostic accuracy of outpatient Holter monitoring to diagnose vasomotor disorders using the coronary function test results as the reference standard
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start3 Dec 2024
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim P. van de Hoef, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387693
- Sponsor's protocol ID
- 24U-1359
- Acronym
- (AI)NOCA
- Status last verified
- Jan 2026
- First submitted
- 3 Apr 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-assisted Diagnostics In Angina With No Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06387693
- Acronym / sponsor ID
- (AI)NOCA / 24U-1359
- Conditions
- Angina, Stable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Apr 2024 (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.
Angina pectoris is diagnosed in >180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.
The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.
During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Diagnostic Test: Holter monitoring, intracoronary ECGIntracoronary ECG and Holter ECG monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical indication for comprehensive coronary function testing because of persisting chest discomfort at least 2 times per week despite current medical therapy.
- Absence of obstructive coronary artery disease with an indication for revascularization, documented by means of recent coronary computed tomography angiography (CCTA) or invasive coronary angiography (with invasive coronary pressure measurements if clinically indicated).
- Patient is willing and able to provide written informed consent.
Key exclusion criteria (2 listed)
- Absence of chest discomfort after initiation of medical therapy.
- Language barrier preventing sufficient understanding and communication in Dutch.
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 |
|---|---|---|
| Holter monitoring, intracoronary ECGHolter monitoring device to track ECG abnormalities during spontaneous chest pain in the outpatient setting. Intracoronary ECG to evaluate perprocedural ECG responses | Diagnostic test | Single arm |
Primary outcome
Prevalence of myocardial ischemia in patients with equivocal coronary function test results
Time frame: During the procedure
The prevalence of ischemic changes on the intracoronary ECG in patients with equivocal coronary function test results.
Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders
Time frame: During the procedure
Accuracy of the Holter ECG to identify ischemic ECG changes compared with the standard 12-lead ECG during acetylcholine-provoked chest pain.
Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders
Time frame: 7 days
Diagnostic accuracy of outpatient Holter monitoring to diagnose vasomotor disorders using the coronary function test results as the reference standard
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 12 Jan 2026.
- Individual participant dataSharing planned: Yes. IPD will be made available upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter monitoring, intracoronary ECG in people with Angina, Stable, run by UMC Utrecht at 1 site in Netherlands.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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 Netherlands. 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 Tim P van de Hoef, MD, PhD (+3188755555, t.p.vandehoef@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of myocardial ischemia in patients with equivocal coronary function test results (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.