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NCT05635994
Advanced Invasive Diagnosis for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy (AID-ANGIO)
Conditions: Chronic Coronary Syndrome, Coronary Artery Disease, Microvascular Angina, Coronary Vasospasm, Myocardial Ischemia
Sex: All
Ages: 18 Years – 90 Years
Enrollment: 260
Sponsor: Hospital San Carlos, Madrid
Location: Spain
Summary
AID-ANGIO is an observational, prospective, single arm, longitudinal study.
Its objective is to investigate the diagnostic yield of the systematic use of a diagnostic strategy hierarchically addressing both obstructive and non-obstructive causes of myocardial ischaemia in an all-comers population of patients with chronic coronary syndromes (CCS) undergoing invasive coronary angiography (ICA).
Angiographically severe-grade stenosis (≥70%) can be safely considered flow-limiting 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.
The main hypothesis of AID-ANGIO study states that, in patients with CCS referred to ICA, the application of a structured strategy -including ICA, physiological assessment of intermediate-grade stenosis and functional coronary tests- leads to a high diagnostic accuracy.
Eligibility Criteria
Inclusion Criteria:Patients with CCS, referred to ICA by their clinicians, suffering from angina and/or positive evidence of ischaemia in non-invasive tests and/or presence of CAD in computed tomography angiography.Exclusion Criteria:Age <18 or >90 years old.Pregnancy.Severe left ventricle systolic dysfunction (LVEF ≤30%) or congestive heart failure.Any concomitant severe valve disease.
Severely decreased renal function (glomerular filtration rate <30 mL/min/1.73
m2).Previous CABG.Presence of any anatomic features hampering intracoronary instrumentation with pressure guidewires.Contraindications to the administration of adenosine (asthma, 2nd or 3rd grade atrioventricular block without pacemaker, history of a non-ablationed accessory pathway-mediated tachycardia) or acetylcholine (asthma, 2nd or 3rd grade atrioventricular block without pacemaker, paroxysmal atrial fibrillation).
Source: ClinicalTrials.gov (NCT05635994). StuddyBuddy aggregates publicly available trial information.