Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05635994
Status:
RECRUITING
Last Update Posted:
2022-12-02
First Post:
2022-11-14
Brief Title:
Advanced Invasive Diagnosis for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy AID-ANGIO
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Advanced Invasive Diagnosis AID Strategy for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy AID-ANGIO
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AID-ANGIO
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 andor 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
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 andor 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 patients 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 patients 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
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 patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None