Effect of hyperemic state on angiography-derived microcirculatory resistance
Official title: The Impact of Hyperemic State on the Performance of Angiography Derived Indices in Assessing Coronary Microvascular Disease
Run by Shanghai Zhongshan Hospital · NCT07613996 · Data updated 2026-11-12
This study tests whether Angio-IMR values from five software programs, measured at three different states (rest, nitroglycerin sub-hyperemia, and maximal adenosine hyperemia), accurately diagnose coronary microvascular disease in patients with stable angina or suspected CAD.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 192 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 2 sites (Shanghai, Please Select and 1 other locations) |
| Status | Recruiting |
| Started | May 4, 2026 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07613996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with stable angina or suspected CAD scheduled for coronary angiography and physiological assessment, with target vessel criteria.
✕Probably not a fit
Patients with non-cardiac-related symptoms or those not meeting the target vessel criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter diagnostic accuracy study that compares five Angio-IMR software programs against the wire-based IMR reference. Each participant undergoes coronary angiography with three angiographic assessments captured at distinct physiological states and a wire-based IMR measurement under maximal hyperemia. Analysts blinded to clinical data will compute Angio-IMR with software A–E, and results will be compared to the gold standard to determine diagnostic performance. The study uses a self-controlled design, allowing within-patient comparisons across states to evaluate how hyperemia affects accuracy and consistency. A centralized core laboratory at Zhongshan Hospital will oversee image analysis.
Why it matters
Potential benefit: If successful, noninvasive Angio-IMR assessments could improve CMD diagnosis and reduce reliance on invasive measurements.
How similar studies have gone: Prior work suggests Angio-IMR-based measures can reflect microvascular function, but cross-vendor consistency and hyperemia effects require validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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%.
Where it's running
-
Zhongshan Hospital, Fudan University
Shanghai, Please Select, China Recruiting -
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China Recruiting
Study contacts
- Study coordinator: Chenguang Li, MD, PhD
- Email: li.chenguang@zs-hospital.sh.cn
- Phone: 021 6404 1990
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.