Chronic Coronary SyndromeAID-ANGIONCT05635994
Advanced Invasive Diagnosis for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy (AID-ANGIO)
An observational study of Chronic Coronary Syndrome and Coronary Artery Disease, run by Hospital San Carlos, Madrid at 4 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Coronary Syndrome, Coronary Artery Disease, Microvascular Angina
- What is being tested?
- AID strategy
- How many people
- 260 participants
- Where
- 4 sitesSpain
- Study dates
- 14 Jun 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comer study population of patients with CCS referred to ICA.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
Alberto García Lledó, MD, PhD, +34 91 8878100, josealberto.garcia@salud.madrid.org
- Recruiting
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Carmen Cristobal, MD, +34 91 6006000, carmen.cristobal@salud.madrid.org
- Recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Inmaculada Fernández-Rozas, MD, +34 91 4818000, ifrozas@salud.madrid.org
- Recruiting
Hospital Clinico San Carlos
Madrid, 28005
Javier Escaned, MD, PhD, 0034913303438 ext. 3438, escaned@secardiologia.es
Javier Escaned, MD, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Coronary Syndrome, Coronary Artery Disease, Microvascular Angina, Coronary Vasospasm, Myocardial Ischemia
- Being tested
- AID strategy
- Keywords
- Chronic Coronary Syndrome, Microvascular Angina, Functional Coronary Angiography, Myocardial Ischemia
- Medical subject headings
- Coronary Artery Disease, Microvascular Angina, Coronary Vasospasm, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AID strategyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: AID strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
To investigate the influence of a structured AID strategy on the treatment plan in patients with CCS.
Measured: 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.
To study the prevalence of CMD in an all-comers population of patients with CCS referred to ICA.
Measured: From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start14 Jun 2022
- Primary completion20 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Responsible party
- Principal investigator, Javier Escaned, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635994
- Sponsor's protocol ID
- 22/193-E
- Acronym
- AID-ANGIO
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39773829
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Invasive Diagnosis (AID) Strategy for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy (AID-ANGIO)
- ClinicalTrials.gov ID
- NCT05635994
- Acronym / sponsor ID
- AID-ANGIO / 22/193-E
- Conditions
- Chronic Coronary Syndrome, Coronary Artery Disease, Microvascular Angina, Coronary Vasospasm, Myocardial Ischemia
- Keywords
- Chronic Coronary Syndrome, Microvascular Angina, Functional Coronary Angiography, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Diagnostic Test: AID strategyThere 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comer study population of patients with CCS referred to ICA.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AID strategyAID 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. | Diagnostic test | Single arm |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 39773829Jeronimo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Syndrome and Coronary Artery Disease, run by Hospital San Carlos, Madrid at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Escaned, MD, PhD ((0034)913303000 ext. 3438, escaned@secadiologia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.