Impact of Hyperemic State on Angio-IMR Performance
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jinying Zhou, MD, PhD
- Correo electrónico: zhou.jinying@zs-hospital.sh.cn
Copia de seguridad de contactos de estudio
- Nombre: Chenguang Li, MD, PhD
- Número de teléfono: 021 6404 1990
- Correo electrónico: li.chenguang@zs-hospital.sh.cn
Ubicaciones de estudio
-
-
-
Guangzhou, Porcelana
- Reclutamiento
- The First Affiliated Hospital, Sun Yat-sen University
-
Contacto:
- Xun Hu, MD, PhD
- Número de teléfono: 020-87608185
- Correo electrónico: hxun@mail.sysu.edu.cn
-
-
Please Select
-
Shanghai, Please Select, Porcelana, 200000
- Reclutamiento
- Zhongshan Hospital, Fudan University
-
Contacto:
- Jinying Zhou, MD, PhD
- Número de teléfono: 021 6404 1990
- Correo electrónico: zhou.jinying@zs-hospital.sh.cn
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
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%.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Single cohort, self-controlled
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area Under the ROC Curve (AUC)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic Accuracy
Periodo de tiempo: Baseline
|
Sensitivity, specificity, positive predictive value, negative predictive value.
|
Baseline
|
|
Correlation
Periodo de tiempo: Baseline
|
Pearson/Spearman coefficients between Angio-IMR and Wire-IMR.
|
Baseline
|
|
Agreement
Periodo de tiempo: Baseline
|
Bland-Altman analysis (Bias and Limits of Agreement).
|
Baseline
|
|
Inter-vendor Agreement
Periodo de tiempo: Baseline
|
Consistency between different software brands.
|
Baseline
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B2026-265
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Angiography-derived IMR
-
Cardurion Pharmaceuticals, Inc.Imara, Inc.RetiradoInsuficiencia cardíaca con fracción de eyección conservada
-
Consorzio Futuro in RicercaTerminadoAngina de pecho refractariaItalia
-
University Hospital, AkershusTerminadoTrastorno bipolar | Psicosis | Otros diagnósticos y condicionesNoruega
-
Imara, Inc.Activo, no reclutandoAnemia drepanocíticaEstados Unidos, Reino Unido
-
University of WashingtonTerminadoEsquizofrenia | Trastorno bipolar | Enfermedad mental grave
-
Cardurion Pharmaceuticals, Inc.Imara, Inc.Terminadoβ talasemiaIsrael, Francia, Malasia, Pavo, Dinamarca, Georgia, Grecia, Italia, Líbano, Marruecos, Países Bajos, Túnez, Reino Unido
-
Cardurion Pharmaceuticals, Inc.Imara, Inc.TerminadoAnemia drepanocíticaEstados Unidos, Omán, Italia, Reino Unido, Líbano, Grecia, Marruecos, Túnez, Ghana, Kenia, Países Bajos, Senegal, Uganda
-
Cardurion Pharmaceuticals, Inc.Imara, Inc.TerminadoAnemia drepanocíticaEstados Unidos, Reino Unido
-
Jaroslaw MichalowskiNational Science Centre, PolandTerminadoMiedo al fracasoPolonia
-
University of AmsterdamVU University of Amsterdam; Stichting Achmea Slachtoffer en SamenlevingAún no reclutandoDependencia Afectiva PatológicaPaíses Bajos, Italia