Advanced Invasive Diagnosis for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy (AID-ANGIO)

NCT05635994 | Unknown

• 1 other identifier: 22/193-E
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Chronic Coronary Syndrome; Coronary Artery Disease; Microvascular Angina; Coronary Vasospasm; Myocardial Ischemia

Keywords

Chronic Coronary Syndrome; Microvascular Angina; Functional Coronary Angiography; Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• Number of patients with a definite diagnosis of a cause of myocardial ischemia after ICA and an AID strategy.

  To investigate the additional diagnostic value of an AID strategy over ICA alone in an all-comer population of patients with CCS.

  From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.

Secondary Outcomes (2)

• Number of patients in which the application of an AID strategy leads to a change from the initial treatment plan, only based in clinical information and ICA findings.

  From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.

• Number of patients with CMD, defined as low CFR or high IMR.

  From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.

Study Arms (1)

Single arm

There is only one arm. Initially, a tentative diagnosis would be performed by the clinician, only taking into account patients's clinical information and angiography images. After applying AID strategy, a final diagnosis will be reached and compared with the tentative one.

Diagnostic Test: AID strategy

Interventions

AID strategy DIAGNOSTIC_TEST

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 (≥70%) can be safely considered flow-limiting without further physiological assessment. Conversely, by means of a pressure guidewire, intermediate-grade stenosis should 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.

Single arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comer study population of patients with CCS referred to ICA.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Fundacion Investigacion Interhospitalaria Cardiovascular: collaborator

Study Sites (4)

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

RECRUITING

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28005, Spain

RECRUITING

Related Publications (1)

• Jeronimo A, Paredes-Vazquez JG, Travieso A, Shabbir A, Jimenez-Quevedo P, Macaya-Ten F, Nombela-Franco L, Nunez-Gil IJ, Salinas P, Gomez-Polo JC, Garcia-Arribas D, Vilacosta I, Perez-Velasco JG, Garcia-Romo E, Garcia-Lledo A, Grande-Ingelmo JM, Fernandez-Rozas I, Alonso-Bello J, Curcio A, Fernandez-Ortiz AI, Villacastin JP, Mejia-Renteria H, Gonzalo N, Escaned J. Comprehensive diagnosis in chronic coronary syndromes combining angiography and intracoronary testing: the AID-ANGIO study. EuroIntervention. 2025 Jan 6;21(1):35-45. doi: 10.4244/EIJ-D-24-00499.

  PMID: 39773829 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Microvascular Angina; Coronary Vasospasm; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris

Central Study Contacts

Javier Escaned, MD, PhD

CONTACT

(0034)913303000; escaned@secadiologia.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interventional Cardiology

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 2, 2022
• Study Start: June 14, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 30, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)