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临床试验/NCT06387693
NCT06387693招募中不适用

Artificial Intelligence-assisted Diagnostics In Angina With No Obstructive Coronary Artery Disease

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
UMC Utrecht
入组人数
250
试验地点
1
主要终点
Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Single arm

Experimental

Intracoronary ECG and Holter ECG monitoring

干预措施: Holter monitoring, intracoronary ECG (Diagnostic Test)

结局指标

主要结局

Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders

时间窗: 7 days

Diagnostic accuracy of outpatient Holter monitoring to diagnose vasomotor disorders using the coronary function test results as the reference standard

Prevalence of myocardial ischemia in patients with equivocal coronary function test results

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tim P. van de Hoef

Principal Investigator

UMC Utrecht

研究点 (1)

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