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Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography

4 de junio de 2026 actualizado por: Javier Escaned, Fundacion Investigacion Interhospitalaria Cardiovascular

Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography: the AID Post-PCI Angina Study

AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study designed to investigate the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI), who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA) will be enrolled. ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. Then, angiography derived physiological assessment of epicardial coronary artery using functional coronary angiography in each vessel will be performed in both index procedure and the previous procedure in all patients. By combining information obtained from both procedures, the causes and origins of post-PCI angina will be made. Treatment will be decided by the operators according to the result. Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months after the procedure. The main hypothesis of this study states that, in patients with post-PCI angina referred to ICA, the application of the structured AID strategy combining with angiography derived physiology (ADP) will lead to a high diagnostic yield in identifying the origins of obstructive disease and causes of post-PCI angina.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study intended to investigate for the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. Secondary objective is to investigate the benefits of applying the AID strategy in the improvement of angina symptoms at 6 months, evaluated by the Seattle Angina Questionnaire (SAQ). This study is a multicenter study and will be conducted in 5 hospitals across Spain.

An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for ICA at participating centers, will be enrolled in the study.

After acquiring patient's informed consent, ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. AID strategy begins with invasive coronary angiography. Angiographically severe-grade stenosis (≥90%) can be safely considered as cause of a myocardial ischemia without further physiological assessment. Conversely, by means of a pressure guidewire, intermediate-grade stenosis would be evaluated with fractional flow reserve (FFR) and/or non-hyperaemic pressure ratios (NHPR) in order to determine if they are physiologically relevant. Those patients with non-obstructive CAD or normal epicardial coronary arteries would undergo functional coronary tests to investigate the presence of microcirculatory and vasomotor coronary disorders, which would account for non-obstructive causes of ischaemia. Patient's angiograms in both index procedure and previous PCI will be assessed by functional coronary angiography using the AngioPlus Core software (Pulse Medical Technology, Shanghai, China) for angiography derived physiology (ADP). By combining the results from the AID strategy and ADP, origin of obstructive disease can be defined as progression of CAD, post-PCI residual disease, suboptimal stenting and in stent restenosis (ISR.

Treatment will be decided by the operators according to the result. Patient will be follow-up at 1, 6, and 12 months after the procedure. At each follow-up, patients will complete the Seattle Angina Questionnaire (SAQ) to evaluate for angina symptom.

Tipo de estudio

De observación

Inscripción (Estimado)

246

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Javier Escaned, MD, PhD
  • Número de teléfono: 3438 (0034)913303000
  • Correo electrónico: escaned@secadiologia.es

Ubicaciones de estudio

  • España
    • Madrid
      • Leganés, Madrid, España, 28911
        • Reclutamiento
        • Hospital Universitario Severo Ochoa
        • Contacto:
      • Madrid, Madrid, España, 28007
        • Reclutamiento
        • Hospital General Universitario Gregorio Marañón
        • Contacto:
      • Madrid, Madrid, España, 28005
        • Reclutamiento
        • Hospital Clinico San Carlos
        • Contacto:
          • Javier Escaned, MD, PhD
          • Número de teléfono: ext 3438 (0034)913303000
          • Correo electrónico: escaned@secadiologia.es
      • Madrid, Madrid, España, 28805
    • Valencia
      • Valencia, Valencia, España, 46010
        • Reclutamiento
        • Hospital Quironsalud Valencia
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for ICA at participating centers.

Descripción

Inclusion Criteria:

  • Patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography.

Exclusion Criteria:

  • Acute myocardial infarction (ST-segment elevation myocardial infarction [STEMI] and non-ST-segment elevation myocardial infarction [NSTEMI]).
  • Age < 18 years old.
  • Pregnancy.
  • Severe left ventricle systolic dysfunction (left ventricular ejection fraction ≤30 %).
  • Congestive heart failure with reduced ejection fraction.
  • Concomitant severe valvular heart disease.
  • Severely decreased renal function (glomerular filtration rate < 30 mL/min/1.73 m2).
  • Significant epicardial coronary artery disease unable to be treated by PCI.
  • Previous coronary artery bypass grafting (CABG).
  • Presence of any anatomic features precluding intracoronary instrumentation with pressure guidewires.
  • Contraindications to the administration of adenosine or acetylcholine.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Patients with Post-PCI Angina
An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA).
Prueba de diagnóstico: An advanced invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP)

AID strategy encompasses a hierarchical algorithm intended to investigate both obstructive and non-obstructive causes of myocardial ischaemia. AID strategy starts with an ICA. Angiographically severe-grade stenosis (≥90%) can be safely considered flow-limiting without further physiological assessment. Conversely, by means of a pressure guidewire, intermediate-grade stenosis will be evaluated with FFR and/or NHPR in order to determine if they are physiologically significant. Those patients with non-obstructive CAD or normal epicardial coronary arteries should undergo functional coronary tests to investigate the presence of microcirculatory and vasomotor coronary disorders, which would account for non-obstructive causes of ischaemia.

Angiography derived physiology will be performed by applying functional coronary angiography to the coronary angiogram using AngioPlus Core software (Pulse Medical Technology, Shanghai, China).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The proportion of patients in whom the origins of obstructive disease and causes of post-PCI angina is identified using the AID strategy combining with ADP.
Periodo de tiempo: Baseline.

To establish the obstructive and non-obstructive causes of post-PCI angina and the origins of obstructive disease in an all-comers population of patients referred for invasive angiography using the AID strategy combining with ADP. The origins of obstructive disease can be classified as

  • Progression of CAD: the presence of a new hemodynamically significant stenosis outside the previous stent(s) which was not detectable by the previous angiogram (Previous PCI µFR>0.80).
  • Post-PCI residual disease: the presence of a hemodynamically significant stenosis outside the stent(s) segment, which was detectable by the previous angiogram (Previous PCI µFR≤0.80).
  • Suboptimal stenting: the presence of a hemodynamically significant stenosis within the stented segment, which was detectable by the previous angiogram (Previous PCI µFR≤0.80).
  • In stent restenosis (ISR): the presence of a hemodynamically significant stenosis inside the stented segment which was not detectable by the previous angiogram
Baseline.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The improvement of angina symptom at 6 months
Periodo de tiempo: From the date of enrollment to the 6 month follow up.
To investigate the benefits of applying the advance invasive diagnosis (AID) strategy in the improvement of angina symptoms at 6 months, evaluated by the Seattle Angina Questionnaire (SAQ). The SAQ score will be reported on a scale of 0-100 with the higher score means less angina symptom (better outcome).
From the date of enrollment to the 6 month follow up.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fundacion Investigacion Interhospitalaria Cardiovascular

Colaboradores

Instituto de Salud Carlos III

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de marzo de 2025

Finalización primaria (Estimado)

30 de marzo de 2027

Finalización del estudio (Estimado)

30 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

28 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 22/193E

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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