Clinical trial NCT05855538: Clinical Cohorts for Validation of New Digital Biomarkers
Official title: Machine Learning and Artificial Intelligence for Early Detection of Stroke and Atrial Fibrillation. Clinical Cohorts for Validation of New Digital Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Atrial Fibrillation Network
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: European prospective cohort of patients with diagnosed AF.

Patients are distributed in 3 groups according to the different clinical manifestation of AF:

1. Patients with paroxysmal AF (clinically defined as AF episodes less than one week), or
2. Patients with persistent AF (clinically defined as AF episodes longer than one week), or
3. Patients with permanent AF (no documented sinus rhythm or possibility to restore sinus rhythm by any means)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Physical examination
timeFrame: 12 months
measure: Clinically relevant changes in CT/MRI
timeFrame: 12 months
measure: Atrial Arrythmias (AA) burden and vascular stiffness (measured by a measuring bracelet)
timeFrame: 12 months
measure: Cognitive function test (MoCA)
timeFrame: Baseline and Follow up at 12 months
measure: EQ-5D-5L Quality of Life questionnaire
timeFrame: Baseline and Follow up at 12 months
measure: Ischaemic events (systemic, myocardial and cerebral)
timeFrame: 12 months
measure: Echo analysis (TEE_transesophageal echocardiography): LAA smoke available
timeFrame: 12 months
measure: Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA
timeFrame: 12 months
measure: Echo analysis (TEE_transesophageal echocardiography): Antrum diameter
timeFrame: 12 months
measure: Echo analysis (TTE_transthoracic echocardiography): LVEF
timeFrame: 12 months
measure: Echo analysis (TTE_transthoracic echocardiography): LA diameter
timeFrame: 12 months
measure: Echo analysis (TTE_transthoracic echocardiography): LA volume
timeFrame: 12 months
measure: Echo analysis (TTE_transthoracic echocardiography): Septum thickness
timeFrame: 12 months
measure: Echo analysis (TTE_transthoracic echocardiography): Degree of mitral valve insufficiency
timeFrame: 12 months
measure: Echo analysis (TTE_transthoracic echocardiography): Degree of tricuspid valve insufficiency
timeFrame: 12 months
measure: ECG analysis
timeFrame: 12 months
measure: MRI analysis: LAEF
timeFrame: 12 months
measure: MRI analysis: LAVi
timeFrame: 12 months
measure: MRI analysis: LALRS
timeFrame: 12 months
measure: MRI analysis: LALBS
timeFrame: 12 months
measure: CT scan analysis
timeFrame: 12 months
Secondary outcomes:
measure: CT scan: Atriomic risk for AF
timeFrame: 12 months
measure: CT scan: Epicardial Adipose tissue volume
timeFrame: 12 months
measure: CT scan: Epicardial adipose tissue mean attenuation
timeFrame: 12 months
measure: CT scan: Left atrium volume
timeFrame: 12 months
Other outcomes:
Locations:
city: Paderborn
country: Germany
facility: St Vincenz Hospital
Study officials:
affiliation: ICAN Nutrition Education and Research
name: Stéphan Hatem, Prof
role: STUDY_DIRECTOR
References: