Hospital Clínico San Carlos IdISSC, Universidad Complutense de Madrid, Profesor Martín Lagos s/n, 28040, Madrid, Spain.
Hospital Universitario Severo Ochoa, M-402 s/n, 28914 Leganés, Madrid, Spain.
Cardiovasc Revasc Med. 2023 Aug;53:45-50. doi: 10.1016/j.carrev.2023.03.007. Epub 2023 Mar 23.
The diagnostic yield of invasive coronary angiography (ICA) to identify obstructive coronary artery disease in the context of chronic coronary syndromes (CCS) is very low. Furthermore, myocardial ischemia may have a non-obstructive origin, which cannot be detected by ICA.
AID-ANGIO is an observational, prospective, single-cohort, multicenter study, intended to evaluate the diagnostic yield of adopting a hierarchical strategy to assess obstructive and non-obstructive causes of myocardial ischemia in an all-comers population of patients with CCS at the time of ICA. The primary endpoint will investigate the additional diagnostic value of such strategy over angiography alone regarding the identification of ischemia-generating mechanisms.
An estimated sample of consecutive 260 patients with CCS referred by their clinicians to ICA, will be enrolled. In a stepwise manner, a conventional ICA will be performed as the initial diagnostic tool. Those patients with severe-grade stenosis will not undergo further assessment and an obstructive origin for myocardial ischemia will be assumed. Subsequently, the remainder with intermediate-grade stenosis will be assessed with pressure guidewires. Those with a negative result from physiological evaluation and those without epicardial coronary stenosis will be further studied for ischemia of non-obstructive origin, including microvascular dysfunction and vasomotor disorders. The study will be conducted in two steps. Firstly, ICA images will be displayed to patient's referring clinicians, who will be asked to identify the existent epicardial stenosis, their angiographic severity and probable physiological relevance, together with a tentative therapeutic approach. Then, the diagnostic algorithm will continue to be applied and, considering the whole gathered information, a definite therapeutic plan will be consensually established by the interventional cardiologist and patient's referring clinicians.
The AID-ANGIO study will assess the additional diagnostic yield of a hierarchical strategy over ICA alone to identify ischemia-generating mechanisms in patients with CCS and its impact on therapeutic approach. Positive results of the study might support a streamlined invasive diagnostic process for patients with CCS.
在慢性冠状动脉综合征（CCS）背景下，进行有创冠状动脉造影（ICA）以确定阻塞性冠状动脉疾病的诊断率非常低。此外，心肌缺血可能具有非阻塞性起源，这无法通过 ICA 检测到。
AID-ANGIO 是一项观察性、前瞻性、单队列、多中心研究，旨在评估在所有接受 ICA 的 CCS 患者人群中采用分层策略评估心肌缺血的阻塞性和非阻塞性原因的诊断率。主要终点将研究这种策略相对于单独进行血管造影在确定产生缺血的机制方面的额外诊断价值。
预计将连续招募 260 名由其临床医生转诊至 ICA 的 CCS 患者。将逐步进行常规 ICA 作为初始诊断工具。那些存在严重程度狭窄的患者将不会进行进一步评估，并假定心肌缺血具有阻塞性起源。随后，那些存在中度狭窄的患者将使用压力导丝进行评估。那些生理评估结果为阴性且没有心外膜冠状动脉狭窄的患者将进一步研究非阻塞性起源的缺血，包括微血管功能障碍和血管舒缩障碍。该研究将分两步进行。首先，将向患者的转诊临床医生展示 ICA 图像，要求他们识别存在的心外膜狭窄、其血管造影严重程度和可能的生理相关性，以及初步的治疗方法。然后，将继续应用诊断算法，并根据收集到的所有信息，由介入心脏病专家和患者的转诊临床医生共同制定明确的治疗计划。
AID-ANGIO 研究将评估分层策略相对于单独 ICA 对确定 CCS 患者产生缺血的机制的额外诊断率及其对治疗方法的影响。研究的阳性结果可能支持对 CCS 患者进行简化的有创诊断流程。
