Impact of Hyperemic State on Angio-IMR Performance

May 21, 2026 updated by: Junbo Ge, Shanghai Zhongshan Hospital

The Impact of Hyperemic State on the Performance of Angiography Derived Indices in Assessing Coronary Microvascular Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Overview and Procedural Protocol

This is a prospective, multi-center, diagnostic accuracy study employing a self-controlled design. All participants will undergo coronary angiography and physiological assessment according to standard clinical indications. During the procedure, specific angiographic images will be systematically captured for the target vessel at three distinct physiological time points:

Resting State: Baseline coronary angiography without any hyperemic agents. Sub-hyperemic State: Following the intracoronary administration of nitroglycerin.

Maximal Hyperemic State: During continuous intracoronary infusion of adenosine to achieve maximal microvascular vasodilation.

Immediately following image acquisition, the reference standard measurement-Wire-IMR-will be performed using a pressure-sensor-equipped guidewire under maximal hyperemia.

Core Laboratory Imaging Analysis and Blinding

All angiographic data will be de-identified and transferred to a centralized, independent Cardiovascular Imaging Core Laboratory at Zhongshan Hospital, Fudan University. The analysis will be conducted as follows:

Software Platforms: Five different commercially available Angio-IMR software platforms (anonymized as A, B, C, D, and E) will be used to calculate microvascular resistance.

Independent Analysis: Five dedicated analysts, each specialized in one specific software platform, will perform the calculations. Each analyst will be blinded to the patients' clinical information, the Wire-IMR gold standard results, and the results from the other four software platforms.

Standardization: A primary researcher, not involved in the software measurements, will pre-define the target vessel segments and measurement frames to ensure consistency across all five software platforms.

Statistical Considerations and Data Management The study aims to determine if the coronary hyperemic state significantly alters the fluid dynamics modeling utilized by Angio-IMR algorithms. AUC will be calculated for each software at each of the three states. A head-to-head comparison of AUCs will be performed using DeLong's test. To maintain data integrity, results from the core laboratory and the clinical centers will remain strictly separated until the final database lock.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
    • Please Select
      • Shanghai, Please Select, China, 200000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Single cohort, self-controlled
Diagnostic test: Angiography-derived IMR
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the ROC Curve (AUC)
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy
Time Frame: Baseline
Sensitivity, specificity, positive predictive value, negative predictive value.
Baseline
Correlation
Time Frame: Baseline
Pearson/Spearman coefficients between Angio-IMR and Wire-IMR.
Baseline
Agreement
Time Frame: Baseline
Bland-Altman analysis (Bias and Limits of Agreement).
Baseline
Inter-vendor Agreement
Time Frame: Baseline
Consistency between different software brands.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Affiliated Hospital, Sun Yat-Sen University
Zhongnan Hospital
The 7th People's Hospital of Zhengzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2026-265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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