Artificial intelligence to find causes of angina with no blocked arteries (ANOCA)
Artificial Intelligence-assisted Diagnostics In Angina With No Obstructive Coronary Artery Disease
This project will test whether AI analysis of intracoronary ECG and Holter monitoring can help identify vasospasm or microvascular problems in people with ongoing angina but no obstructed coronary arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06387693 on ClinicalTrials.gov |
What this trial studies
Many patients with angina have no obstructive coronary stenosis, a condition called ANOCA that is linked to poor quality of life and adverse events. During invasive coronary angiography, coronary function testing (CFT) including intracoronary ECG is used to diagnose vasomotor disorders, but the ECG signs can be subtle and hard to interpret. This project combines intracoronary ECG recordings with ambulatory Holter monitoring and applies artificial intelligence to detect the electrocardiographic signs of ischemia that support a diagnosis of vasospasm or microvascular dysfunction. Participants are patients at UMC Utrecht with frequent chest discomfort despite therapy and no obstructive coronary disease on recent imaging or angiography who can provide informed consent.
Who should consider this trial
Good fit: People who have persistent chest discomfort at least twice per week despite medical therapy, no obstructive coronary artery disease on recent CCTA or invasive angiography, and who can give informed consent (and understand Dutch) are ideal candidates.
Not a fit: Patients with obstructive coronary disease that requires revascularization, those whose chest pain has resolved after therapy, or those unable to communicate in Dutch are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this approach could improve detection of vasospasm and microvascular causes of angina, leading to more targeted treatment and better symptom control.
How similar studies have performed: Coronary function testing and intracoronary ECG are established methods for diagnosing vasomotor disorders, but applying AI to intracoronary ECG and Holter data for ANOCA is a novel approach that has not yet been proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1. Absence of chest discomfort after initiation of medical therapy. 2. Language barrier preventing sufficient understanding and communication in Dutch.
Where this trial is running
Utrecht
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Tim P van de Hoef, MD, PhD
- Email: t.p.vandehoef@umcutrecht.nl
- Phone: +3188755555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.