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疑似心肌缺血和非阻塞性冠状动脉患者预后分层的国家多中心登记研究ESP-INOCA:原理与设计

ESP-INOCA: Rationale and design of a national multicentre registry for prognostic stratification in patients with suspected myocardial ischaemia and non-obstructive coronary arteries.

作者信息

Rumiz Eva, Rivero Fernando, Pérez Ainhoa, Nau Gerardo, Romero Manuela, Solana Santiago, Jurado Alfonso, Fuertes Georgina, Pardo Ana, Gutiérrez-Barrios Alejandro, Casanova Juan, Oteo Juan Francisco, Frutos Araceli, Salvatella Neus, Cardenal Rosa, Sabatel Fernando, Cortés Carlos, Valero Ernesto, Rodríguez Rocío, Gutierrez Enrique, López-Palop Ramón, Escaned Javier

机构信息

Cardiology Department, Consorcio Hospital General Universitario, Universitat de València, Valencia, Spain; Cardiology Department, Hospital QuironSalud, Valencia, Spain.

Cardiology Department, Hospital Universitario La Princesa, Madrid, Spain.

出版信息

Int J Cardiol. 2025 Aug 29;442:133845. doi: 10.1016/j.ijcard.2025.133845.

DOI:10.1016/j.ijcard.2025.133845
PMID:40886802
Abstract

INTRODUCTION

Obstructive coronary artery disease (CAD) has long been recognized as the primary mechanism underlying myocardial ischaemia. However, up to 50 % of patients with angina and objective evidence of ischaemia present with non-obstructed coronary arteries (INOCA) in the coronary angiography, falling under the umbrella term INOCA, a heterogeneous group that remains frequently underdiagnosed and undertreated. Performing a coronary function test (CFT) enables us to diagnose and stratify these patients into different endotypes and start a targeted medical therapy. This study aims to determine the prevalence and long-term clinical outcomes of the different INOCA endotypes through a nationwide registry.

METHODS AND RESULTS

ESP-INOCA (ClinicalTrials.gov Identifier: NCT06327672) is a Spanish multicentre, observational, longitudinal and prospective registry enrolling patients with chronic coronary syndromes and suspected myocardial ischaemia, referred for invasive coronary angiography. Patients are included if no obstructive CAD is found and a CFT is performed. Endothelium-independent vascular function will be evaluated through the analysis of coronary flow reserve and index of microvascular resistance using the bolus-thermodilution technique. The presence of coronary vasomotor disorders will be assessed by the acetylcholine test. The primary outcome is a composite of all-cause death, acute myocardial infarction, emergency department visits for acute chest pain, hospital admissions for angina or heart failure at one year of follow-up.

CONCLUSIONS

This large multicentre registry will provide valuable insights into the long-term prognosis of INOCA endotypes, contributing to improved risk stratification and a better understanding of this heterogeneous clinical entity.

摘要

引言

阻塞性冠状动脉疾病(CAD)长期以来一直被认为是心肌缺血的主要机制。然而,在冠状动脉造影中,高达50%的心绞痛患者和有缺血客观证据的患者表现为冠状动脉无阻塞(INOCA),属于INOCA这一统称,这是一个异质性群体,仍然经常被漏诊和治疗不足。进行冠状动脉功能测试(CFT)使我们能够诊断这些患者并将其分层为不同的终末类型,并开始针对性的药物治疗。本研究旨在通过全国性登记确定不同INOCA终末类型的患病率和长期临床结局。

方法和结果

ESP-INOCA(ClinicalTrials.gov标识符:NCT06327672)是一项西班牙多中心、观察性、纵向和前瞻性登记研究,纳入患有慢性冠状动脉综合征和疑似心肌缺血并被转诊进行有创冠状动脉造影的患者。如果未发现阻塞性CAD且进行了CFT,则纳入患者。将通过使用团注热稀释技术分析冠状动脉血流储备和微血管阻力指数来评估内皮非依赖性血管功能。将通过乙酰胆碱试验评估冠状动脉血管舒缩障碍的存在。主要结局是随访一年时全因死亡、急性心肌梗死、因急性胸痛到急诊科就诊、因心绞痛或心力衰竭住院的复合结局。

结论

这项大型多中心登记研究将为INOCA终末类型的长期预后提供有价值的见解,有助于改善风险分层并更好地理解这一异质性临床实体。

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