RecruitingNCT07638137

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

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

Sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Enrollment

246 participants

Start Date

Mar 12, 2025

Study Type

OBSERVATIONAL

Conditions

Chronic Coronary Syndrome Angina, Stable Percutaneous Coronary Intervention (PCI)INOCA (Ischemia With Non Obstructive Coronary Artery Disease)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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 Criteria11

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.

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Interventions

DIAGNOSTIC_TESTAn 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).