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Impact of Hyperemic State on Angio-IMR Performance

Recruitingn/aAges 18 Years - anyAllShanghai Zhongshan Hospital
NCT07613996 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to evaluate the diagnostic performance of angiography-derived microcirculatory indices (Angio-IMR) in assessing patients with stable angina or suspected coronary artery disease. The main questions it aims to answer are: How do the numerical values of Angio-IMR from five different software vendors change across three physiological states (resting, sub-hyperemia induced by nitroglycerin, and maximal hyperemia induced by adenosine)? Which physiological state and software algorithm provide the highest diagnostic accuracy (Area Under the Curve, AUC) for diagnosing Coronary Microvascular Disease (CMD) when compared to the gold standard wire-based IMR? Researchers will compare the Angio-IMR results calculated under the three different physiological conditions within the same patient to see how the hyperemic state impacts the performance and consistency o

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📋 Eligibility rules (as published)
Inclusion Criteria: * Stable angina or suspected coronary heart disease. * Scheduled for coronary angiography and physiological assessment. * Target vessel with stenosis \< 50% or 50%-90% with fractional flow reserve (FFR) \> 0.80. * Provided informed consent. Exclusion Criteria: * Hemodynamic instability (acute myocardial infarction, cardiogenic shock, severe arrhythmia). * Contraindications to angiography (e.g., end-stage renal disease). * Contraindications to adenosine (e.g., severe asthma, high-degree atrial-ventricular block). * Life expectancy \< 1 year or pregnancy. * Target vessel unsuitable for wire operation (left main lesion, severe tortuosity) or stenosis \> 90%.
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What it tests

  • Angiography-derived IMR
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Where

2 sites
Zhongshan Hospital, Fudan University
Shanghai, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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