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
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 250 is above the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intracoronary ECG and Holter ECG monitoring
Diagnostic Test: Holter 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
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
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
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
Plan to share: Yes — IPD will be made available upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: A fully anonymized data set containing data from those patients who agreed with data sharing will be available upon reasonable request 12 months after finalization of the study.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Aug 2028, 44 months after the start.
Of 65 non-industry interventional studies with no phase under Angina, Stable, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 44 months is above that.
Counting every sponsor, half of 76 studies reached it within 35 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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