Impact of Hyperemic State on Angio-IMR Performance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

192 Participants
are divided into 1 treatment group
Group A: Single cohort, self-controlled1 intervention

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

1

Diagnostic Accuracy

Sensitivity, specificity, positive predictive value, negative predictive value.

Time frame
Baseline
2

Correlation

Pearson/Spearman coefficients between Angio-IMR and Wire-IMR.

Time frame
Baseline
3

Agreement

Bland-Altman analysis (Bias and Limits of Agreement).

Time frame
Baseline
4

Inter-vendor Agreement

Consistency between different software brands.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Zhongnan Hospital

Collaborator

The 7th People's Hospital of Zhengzhou

Collaborator