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

Recruiting now

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

In brief

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.

Key facts

Study ID: NCT07638137
Run by: Fundacion Investigacion Interhospitalaria Cardiovascular
People needed: 246
Starts: 2025-03-12
Expected to finish: 2028-03-30
Last updated by the study team: 2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Hospital Universitario Severo Ochoa — Leganés, Madrid, Spain (enrolling)
Hospital Clinico San Carlos — Madrid, Madrid, Spain (enrolling)
Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (enrolling)
Acalá de Henares — Madrid, Madrid, Spain (enrolling)
Hospital Quirónsalud Valencia — Valencia, Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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