Stepwise High Risk Individuals Screening for Atrial Fibrillation Using Sequential Clinical-electro-biological Register: the AFRICAT Study (Atrial Fibrillation Research In CATalonia)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 492
- 试验地点
- 2
- 主要终点
- Atrial fibrillation (AF) diagnosis
研究概览
简要总结
The AFRICAT study is a prospective, multicenter, population-based study, which aims to create and apply a sequential screening program for atrial fibrillation (AF) in a high-risk population by integrating clinical, electrocardiographic and biological information. The study will be divided into three different phases of generation, validation and application of a screening program.
In Phase I, from 8,000 individuals aged 65-75 with hypertension and diabetes identified from primary center registries, 100 will be randomly selected . In these patients, the investigators will complete clinical assessment, testing of different pulse-handheld ECG devices (MyDiagnostik, AliveCor and WatchBP) for AF screening, discovery of blood biomarkers for AF (by aptamer technology and RNA expression), and validation of biological candidates from the literature and previous results. All patients will receive Holter monitoring with a wearable device (NuuboTM). In parallel, a predictive risk model for AF will be developed from historical records from the areas in which the study will be carried out.
This Phase I will be followed by a Phase II-validation phase of 400 patients, selected by the predictive model previously mentioned, belonging to the top risk quartile. In these patients, the best biomarkers and devices from phase I will be validated, and patients will be again monitored with the wearable Holter device.
With the results from this validation analysis, a screening program (Phase III) based in the combination of clinical predictors, devices to detect AF (handheld-ECG or pulse wave detectors), blood biomarkers determination and long-term monitoring with wearable Holter. This program will be applied over the whole population targeted by the AFRICAT study, which corresponds to 8,000 patients from 65 to 75 years old, whit hypertension and diabetes mellitus as comorbidities.
详细描述
The study has been approved by the Ethics Committee of Research Institute IDIAP Jordi Gol (P15/047/2015) and by Hospital Universitari Vall d'Hebron Clinical Research Ethics Committee (PR(AG)133-2015). The study will be conducted in compliance with the Declaration of Helsinki. Registry information was collected from the government-run healthcare provider responsible for all inpatient care in Catalonia. All participants will receive written information and thereafter sign informed consent before inclusion, will be selected among the electronic registers from two different health areas in Catalonia, and will be identified by their 10-digit personal identification number assigned to all citizens in Catalonia.
These patients will be given an appointment in their primary care centre and will receive a comprehensive assessment consisting of:
- Clinical characteristics: demographic factors (age, gender, habits); vascular risk factors (hypertension, diabetes, dyslipidemia), medications, comorbidities (especially those related to AF such as coronary disease, heart failure), vital signs (blood pressure, glycaemia, weight and height).
- Electrocardiographic assessment: three different devices will be tested on each participant (MyDiasnostik, AliveCor and WatchBP). A conventional ECG will be performed to be compared with the results from these devices.
- Blood sample collection: a blood sample of 32 cc divided into two serum tubes (8.5 cc), two plasma EDTA tubes (6 cc) and one TempusTM RNA tube (3 cc). Samples will be processed and stored at -20 ºC at the recruiting centre until shipment to Neurovascular Research Laboratory, where the sample bank will be set up.
- Holter ECG monitoring: a Nuubo Holter will be given to each patient to be carried for four weeks. Electrocardiographic devices will be read blindly. The device records, anonymized and encrypted, will be sent for blinded reading to the Rhythm Disorders Unit from Hospital Virgen del Rocio in Seville.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients aged 65-75 with active diagnoses of hypertension (I10) and diabetes (E10.9 E11.9)
排除标准
- •Absence or not accessibility to singular person or its clinical record or/and difficulty to follow the instructions about how managing the devices or/and no acceptation of conditions
- •Chronic inflammatory diseases
- •Active Cancer
- •For Phases II-III: previous diagnosis of AF
结局指标
主要结局
Atrial fibrillation (AF) diagnosis
时间窗: Study visit/1 month monitoring
Absence of discrete P waves together with an irregular, arrhythmic pattern of ventricular activation, more than 30 seconds.
次要结局
未报告次要终点
研究者
Josep Lluís Clua Espuny
PhD Medicine and Surgery
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina