Impact of Hyperemic State on Angio-IMR Performance

NCT07613996 | Recruiting

• 1 other identifier: B2026-265
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 2

Brief Summary

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 of these non-invasive indices. Participants will: Undergo standard-of-care coronary angiography and physiological assessment using a pressure wire for index of microvascular resistance (Wire-IMR) as part of their clinical management. Have their angiographic images captured at three specific time points: at rest, after intracoronary nitroglycerin, and during adenosine-induced maximal hyperemia. Allow their de-identified imaging and clinical data to be analyzed by an independent core laboratory using five different Angio-IMR software platforms to evaluate microvascular function.

Conditions

Coronary Artery Disease; Microvascular Coronary Artery Disease

Keywords

Coronary Physiology; Computational Fluid Dynamics; Index of Microcirculatory Resistance; Angiography-Derived Indices

Outcome Measures

Primary Outcomes (1)

• Area Under the ROC Curve (AUC)

  Comparison of AUC for 5 types of Angio-IMR against Wire-IMR (Gold standard, CMD defined as Wire-IMR ≥ 25) under three states.

  Baseline

Secondary Outcomes (4)

• Diagnostic Accuracy

  Baseline

• Correlation

  Baseline

• Agreement

  Baseline

• Inter-vendor Agreement

  Baseline

Study Arms (1)

Single cohort, self-controlled

Diagnostic Test: Angiography-derived IMR

Interventions

Angiography-derived IMR DIAGNOSTIC_TEST

Unlike the reference standard "Wire-IMR," which requires the advancement of a specialized pressure-sensor guidewire into the distal coronary artery, Angio-IMR is a wire-free technology. It derives microvascular resistance indices purely through computational fluid dynamics (CFD) or specialized mathematical models based on standard coronary angiographic projections. This eliminates the risk of wire-induced vascular injury or spasm.

Single cohort, self-controlled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients (aged 18 and older) clinically diagnosed with stable angina or suspected coronary artery disease who are scheduled to undergo conventional coronary angiography and invasive physiological assessment. Participants are prospectively and consecutively recruited from multiple clinical centers in China. The population specifically targets individuals with non-obstructive coronary arteries (stenosis \< 50%) or those with moderate stenosis (50%-90%) but preserved epicardial flow (FFR \> 0.80), where assessment of coronary microvascular function is clinically indicated to investigate the cause of ischemia.

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Zhongnan Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The 7th People's Hospital of Zhengzhou: collaborator

Study Sites (2)

Zhongshan Hospital, Fudan University

Shanghai, Please Select, 200000, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Chenguang Li, MD, PhD

CONTACT

021 6404 1990; li.chenguang@zs-hospital.sh.cn

Jinying Zhou, MD, PhD

CONTACT

zhou.jinying@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cardiology

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 29, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)