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Recruiting 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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05635994). StuddyBuddy aggregates publicly available trial information.