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

November 22, 2022 updated by: Javier Escaned, Hospital San Carlos, Madrid

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

AID-ANGIO is designed as an observational, prospective, single arm, longitudinal study, intended to assess the diagnostic yield of a hierarchical strategy which investigates both obstructive and non-obstructive causes of myocardial ischaemia in patients with CCS at the time of ICA. The diagnostic algorithm 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. The pressure guidewire to be used in the whole physiological evaluation (both epicardial and microvascular divisions) is the PressureWire X (Abbott) with a Coroventis Coroflow Cardiovascular System (Abbot) console.

After obtaining patients' informed consent, enrolment would encompass two steps. Firstly, a conventional ICA would be performed, according to standard practice. Then, obtained images would be displayed to patient's referring clinicians. They would be asked to identify epicardial stenosis affecting those vessels susceptible of revascularization, if they would be ≥ or <70%, and, in those <70%, if they would think they could be physiologically relevant. They would also be asked about the tentative therapeutic approach they would suggest, only taking into account patient's clinical information and ICA images. All this information would be collected in a written document to which the interventional team would be blinded. Subsequently, AID strategy would continue to be applied as previously described. Information gathered at the end of it would be written in a separated document by the interventional team. Next, referring physician and interventional team would together review the case, considering clinical information, ICA images and all findings from AID strategy application. Suitable cases for coronary artery bypass grafting (CABG), would also be discussed with a cardiovascular surgeon.

The AID-ANGIO study has a main hypothesis and two secondary hypotheses:

  • Main hypothesis: In patients with CCS referred to ICA, the application of a structured AID strategy -including ICA, physiological assessment of intermediate-grade stenosis and functional coronary tests- leads to a high diagnostic accuracy.
  • Secondary hypothesis (1): In patients with CCS referred to ICA, the application of a structured AID strategy leads to a significant change in their treatment.
  • Secondary hypothesis (2): In patients with CCS referred to ICA, the application of a structured AID strategy increases the number of patients diagnosed with coronary microvascular dysfunction (CMD).

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28005
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
        • Sub-Investigator:
          • Hernan Mejia-Renteria, MD, PhD
        • Sub-Investigator:
          • Francesca Finocchiaro, PhD
        • Sub-Investigator:
          • Adrian Jeronimo, MD
        • Sub-Investigator:
          • Alejandro Travieso, MD
        • Sub-Investigator:
          • Nieves Gonzalo, MD, PhD
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
      • Fuenlabrada, Madrid, Spain, 28942
      • Leganés, Madrid, Spain, 28911
        • Recruiting
        • Hospital Universitario Severo Ochoa
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with a definite diagnosis of a cause of myocardial ischemia after ICA and an AID strategy.
Time Frame: From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.
To investigate the influence of a structured AID strategy on the treatment plan in patients with CCS.
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.
Time Frame: From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.
To study the prevalence of CMD in an all-comers population of patients with CCS referred to ICA.
From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Collaborators

Fundacion Investigacion Interhospitalaria Cardiovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Anticipated)

June 20, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/193-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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