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RecruitingNCT06387693(AI)NOCAUpdated Jan 12, 2026

Artificial Intelligence in ANOCA

An interventional study of Holter monitoring, intracoronary ECG in Angina, Stable, sponsored by UMC Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by UMC Utrecht · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Angina, Stable

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Clinical indication for comprehensive coronary function testing because of persisting chest discomfort at least 2 times per week despite current medical therapy.
  2. 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).
  3. Patient is willing and able to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Absence of chest discomfort after initiation of medical therapy.
  2. Language barrier preventing sufficient understanding and communication in Dutch.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Single arm

    Intracoronary ECG and Holter ECG monitoring

    Diagnostic Test: Holter monitoring, intracoronary ECG

Interventions

  • Diagnostic testHolter monitoring, intracoronary ECG

    Holter monitoring device to track ECG abnormalities during spontaneous chest pain in the outpatient setting. Intracoronary ECG to evaluate perprocedural ECG responses

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the procedure

  2. 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.

    Time frame: During the procedure

  3. 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

    Time frame: 7 days

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Yes — IPD will be made available upon reasonable request.

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06387693
Lead sponsor
UMC Utrecht
Responsible party
Tim P. van de Hoef (Principal Investigator, UMC Utrecht) — Principal investigator
First posted
Apr 29, 2024
Start date
Dec 3, 2024
Primary completion
Aug 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 12, 2026

Study contacts

Tim P van de Hoef, MD, PhD
Contact
t.p.vandehoef@umcutrecht.nl
+3188755555

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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