Advanced Invasive Diagnosis for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGI… (NCT05635994) | Clinical Trial Compass
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Advanced Invasive Diagnosis for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy (AID-ANGIO)
Spain260 participantsStarted 2022-06-14
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with a definite diagnosis of a cause of myocardial ischemia after ICA and an AID strategy.
Timeframe: From date of the first inclusion in the study until the date of last inclusion, assessed up to 48 months.