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

4. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

246

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Spanien
    • Madrid
      • Leganés, Madrid, Spanien, 28911
        • Rekrutierung
        • Hospital Universitario Severo Ochoa
        • Kontakt:
      • Madrid, Madrid, Spanien, 28007
        • Rekrutierung
        • Hospital General Universitario Gregorio Marañon
        • Kontakt:
      • Madrid, Madrid, Spanien, 28005
        • Rekrutierung
        • Hospital Clinico San Carlos
        • Kontakt:
      • Madrid, Madrid, Spanien, 28805
    • Valencia
      • Valencia, Valencia, Spanien, 46010
        • Rekrutierung
        • Hospital Quirónsalud Valencia
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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).
Diagnosetest: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The improvement of angina symptom at 6 months
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Mitarbeiter

Instituto de Salud Carlos III

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. März 2025

Primärer Abschluss (Geschätzt)

30. März 2027

Studienabschluss (Geschätzt)

30. März 2028

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 22/193E

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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