Machine Learning and Artificial Intelligence for Early Detection of Stroke and Atrial Fibrillation. Clinical Cohorts for Validation of New Digital Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA
研究概览
简要总结
The MAESTRIA study is an international, multi-centre, non-interventional, observational registry. The main goal is to enrol a representative group of European patients diagnosed with Atrial Fibrillation (AF) to analyse clinical and relevant parameters (digitalised ECG, echocardiograms, cardiac CTs, MRIs and blood biomarkers) that could be used during clinical practise for the diagnosis of atrial cardiomyopathy. The AF patients will be distributed in 3 groups according to the different manifestation of AF: paroxysmal, persistent and permanent AF.
详细描述
Atrial fibrillation (AF) and stroke are major health care problems in Europe. They are most often the clinical expression of atrial cardiomyopathy, which is under-recognised due to the lack of specific diagnostic tools. Multidisciplinary research and stratified approaches are urgently needed to prevent, diagnose, and treat AF and stroke and preempt the AF-related threat to healthy ageing in Europe.
MAESTRIA is a European consortium of 18 clinicians, scientists and pharma industry partners who are at the forefront of research and medical care of AF and stroke patients funded by the EU Horizon 2020 programme (grant number 965286). The Atrial Fibrillation Network (AFNET) is one of the 18 partner institutions in this European consortium.
MAESTRIA will create multi-parametric digital tools based on a new generation of biomarkers that integrate artificial intelligence (AI) processing and big data from cutting edge imaging, electrocardiography and omics technologies. It will develop novel biomarkers, diagnostic tools and personalized therapies for atrial cardiomyopathy.
The MAESTRIA-AFNET 10 Study is an integral part of the MAESTRIA project. The study will collect relevant clinical parameters for AF from patients, this includes ECGs, cardiac CTs, MRIs and echocardiograms. Dedicated core labs will collect and homogenize the clinical data.
For atrial arrhythmias (AA) and vascular stiffness index (VSI) recording, patients will be provided with a measuring bracelet for continuous monitoring of heart rhythm with a photoplethysmographic (PPG) sensor coupled with a smartphone app and the Preventicus Heartbeats® analytic service (Class IIa, CE marked), approved as consumer device. Preventicus is ISO 13485 certified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with paroxysmal AF, persistent AF or permanent AF.
- •Patients (or legally acceptable representative if applicable to country specific regulations) provide written informed consent to participate in the study. The patient has the option to give separate consent to donate extra volume of blood during the routine blood collection, that can be used for biomedical research.
- •Patient is at least 18 years old.
- •Patient must own a smartphone with Apple iOS version 14.5 (or higher) or with Android version 8.0 (or higher).
排除标准
- •Any disease that limits life expectancy to less than 1 year.
- •All persons unable to provide informed consent.
- •All persons exempt from participation in a study or trial by law.
- •Any medical or psychiatric condition which, in the investigator´s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
结局指标
主要结局
Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA
时间窗: 12 months
measured in cm/sec
Echo analysis (TTE_transthoracic echocardiography): LVEF
时间窗: 12 months
Measured in %; Biplane Simpson Method
MRI analysis: LAEF
时间窗: 12 months
Left atrial ejection fractio measured in %
Echo analysis (TTE_transthoracic echocardiography): Septum thickness
时间窗: 12 months
measured in mm Degree of mitral valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None). Degree of tricuspid valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None).
Echo analysis (TTE_transthoracic echocardiography): Degree of mitral valve insufficiency
时间窗: 12 months
Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None
Physical examination
时间窗: 12 months
Weight (Kilograms-Kg) Height (centimeters-cm) Weight and height will be combined to calculate BMI in Kg/m\^2
Clinically relevant changes in CT/MRI
时间窗: 12 months
only if clinically indicated
Cognitive function test (MoCA)
时间窗: Baseline and Follow up at 12 months
evaluation of cognitive function (includes different tasks: visual/executive; naming; memory; attention; language; abstraction; delayed recall; orientation). Total score will be calculated and collected.
Echo analysis (TEE_transesophageal echocardiography): Antrum diameter
时间窗: 12 months
measured in mm
Echo analysis (TTE_transthoracic echocardiography): LA volume
时间窗: 12 months
measured in mL
Echo analysis (TTE_transthoracic echocardiography): Degree of tricuspid valve insufficiency
时间窗: 12 months
Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None
Atrial Arrythmias (AA) burden and vascular stiffness (measured by a measuring bracelet)
时间窗: 12 months
AA burden and vascular stiffness measured by the measuring bracelet
Ischaemic events (systemic, myocardial and cerebral)
时间窗: 12 months
ischaemic events
MRI analysis: LALRS
时间窗: 12 months
LALRS left atrial longitudinal reservoir strain measured in %
MRI analysis: LALBS
时间窗: 12 months
LALBS left atrial longitudinal booster strain measured in %
EQ-5D-5L Quality of Life questionnaire
时间窗: Baseline and Follow up at 12 months
quality of life assessment (includes questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression). The health state code will be collected (calculated as concatenation of 5 scores). Health score from vertical visual analogue scale (0-100) will be collected.
Echo analysis (TEE_transesophageal echocardiography): LAA smoke available
时间窗: 12 months
collected as Yes/No
Echo analysis (TTE_transthoracic echocardiography): LA diameter
时间窗: 12 months
measured in mm LA volume (mL) Septum thickness (mm) Degree of mitral valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None). Degree of tricuspid valve insufficiency (Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None).
CT scan analysis
时间窗: 12 months
The cardiac CTs will be sent to the specialised core lab for analysis. The analysis will include: Atriomic risk of stroke (5 year event risk) Yes/No
ECG analysis
时间窗: 12 months
Electrocardiogram analysis (paper and digital, if available). - 12-lead body surface ECG will be collected. Variables to be collected in the eCRF: Heart Rhythm (Sinus rhythm; Atrial Fibrillation; Continuous pacing; Pacing and AF; other (specify as free text). Heart rate (beats/min) Heart axis (degrees) QRS interval (msec) PR interval (msec) P-wave duration (msec) QT-duration (msec) QTcF (msec) Other relevant ECG findings (to add as free text).
MRI analysis: LAVi
时间窗: 12 months
LAVi left atrial volume index measured in ml/m\^2
次要结局
- CT scan: Atriomic risk for AF(12 months)
- CT scan: Left atrium volume(12 months)
- CT scan: Epicardial Adipose tissue volume(12 months)
- CT scan: Epicardial adipose tissue mean attenuation(12 months)