Schukraft Sara, Mancinetti Marco, Hayoz Daniel, Faucherre Yannick, Cook Stéphane, Arroyo Diego, Puricel Serban
Department of Cardiology, University and Hospital of Fribourg, Chemin des Pensionnats 2, 1708, Fribourg, Switzerland.
Department of General Internal Medicine, University and Hospital of Fribourg, Chemin des Pensionnats 2, 1708, Fribourg, Switzerland.
Trials. 2019 Jan 30;20(1):92. doi: 10.1186/s13063-019-3189-7.
BACKGROUND/RATIONALE: Atrial fibrillation (AF) is frequent and causes great morbidity in the aging population. While initial events may be symptomatic, many patients have silent AF and are at risk of ischemic embolic complications. Timely detection of asymptomatic patients is paramount. The HECTO-AF trial aims to investigate the efficacy of an electrocardiogram (ECG) handheld device for the detection of AF in patients in hospital without a prior diagnosis of AF.
METHODS/DESIGN: The "Handheld ECG tracking of in-hospital atrial fibrillation" (HECTO-AF) study is a single-center, open-label, randomized controlled trial. The study population consists of all adult patients admitted to a general medicine ward of the University and Hospital of Fribourg throughout the study period. The study will enroll 1600 patients with 1:1 ratio allocation to either the detection group with one-lead handheld ECG recordings twice daily and extra recordings in the case of palpitations, versus a control group undergoing detection of AF as per routine clinical practice. Recordings will be self-performed after dedicated training, and will be independently adjudicated through a specific web-based interface. All enrolled patients will be followed clinically at 1, 2 and 5 years to assess the occurrence of AF, death, non-fatal stroke, systemic embolism, myocardial infarction and bleeding. The primary outcome is incidence of newly detected AF during the hospital stay. Secondary outcomes are incidence of AF, cardiovascular death, stroke, myocardial infarction and bleeding complications at 1, 2 and 5 years.
HECTO-AF is an independent randomized study aiming to detect the incidence of silent AF in all-comers hospitalized in general medicine wards.
ClinicalTrials.gov, NCT03197090 . Registered on 23 June 2017. Local ethical Committee (CER-VD) registration number: 2017-01594. There are no conflicts of interest to declare.
背景/原理：心房颤动（AF）在老年人群中很常见，且会导致严重的发病率。虽然初始事件可能有症状，但许多患者有无症状性房颤，并有发生缺血性栓塞并发症的风险。及时检测无症状患者至关重要。HECTO-AF试验旨在研究一种心电图（ECG）手持设备对未预先诊断为房颤的住院患者检测房颤的疗效。
方法/设计：“住院心房颤动的手持心电图追踪”（HECTO-AF）研究是一项单中心、开放标签、随机对照试验。研究人群包括在整个研究期间入住弗里堡大学医院普通内科病房的所有成年患者。该研究将招募1600名患者，按1:1比例分配到检测组，检测组每天进行两次单导联手持心电图记录，心悸时额外记录，对照组则按照常规临床实践检测房颤。记录将在经过专门培训后自行完成，并通过特定的基于网络的界面进行独立判定。所有入组患者将在1年、2年和5年进行临床随访，以评估房颤、死亡、非致命性中风、系统性栓塞、心肌梗死和出血的发生情况。主要结局是住院期间新检测到的房颤发生率。次要结局是1年、2年和5年时房颤、心血管死亡、中风、心肌梗死和出血并发症的发生率。
HECTO-AF是一项独立的随机研究，旨在检测普通内科病房住院的所有患者中无症状性房颤的发生率。
ClinicalTrials.gov，NCT03197090。于2017年6月23日注册。当地伦理委员会（CER-VD）注册号：2017-01594。无利益冲突声明。
