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

4 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

246

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Espanha
    • Madrid
      • Leganés, Madrid, Espanha, 28911
        • Recrutamento
        • Hospital Universitario Severo Ochoa
        • Contato:
      • Madrid, Madrid, Espanha, 28007
        • Recrutamento
        • Hospital General Universitario Gregorio Marañón
        • Contato:
      • Madrid, Madrid, Espanha, 28005
        • Recrutamento
        • Hospital Clinico San Carlos
        • Contato:
      • Madrid, Madrid, Espanha, 28805
    • Valencia
      • Valencia, Valencia, Espanha, 46010
        • Recrutamento
        • Hospital Quironsalud Valencia
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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).
Teste de diagnostico: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
The improvement of angina symptom at 6 months
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Fundacion Investigacion Interhospitalaria Cardiovascular

Colaboradores

Instituto de Salud Carlos III

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

12 de março de 2025

Conclusão Primária (Estimado)

30 de março de 2027

Conclusão do estudo (Estimado)

30 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

28 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 22/193E

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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