Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05635994 |
Other study ID # |
22/193-E |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 14, 2022 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
November 2022 |
Source |
Hospital San Carlos, Madrid |
Contact |
Javier Escaned, MD, PhD |
Phone |
(0034)913303000 |
Email |
escaned[@]secadiologia.es |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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).