Clinical Cohorts for Validation of New Digital Biomarkers (MAESTRIA)

Machine Learning and Artificial Intelligence for Early Detection of Stroke and Atrial Fibrillation. Clinical Cohorts for Validation of New Digital Biomarkers

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Andreas Götte, Prof; Phone Number: +49 05251/86-1651; Email: Andreas.Goette@vincenz.de
• Study Contact Backup: Name: Beatriz Lorente Cánovas, Dr; Phone Number: +49 251 980 1332; Email: beatriz.lorente@af-net.eu

Study Locations

• Germany
  • Paderborn, Germany, 33098
    • Recruiting
    • St Vincenz Hospital
    • Contact: Andreas Götte, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Paroxysmal AF; 200 patients
Persistent AF; 200 patients
Permanent AF; 200 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical examination	Weight (Kilograms-Kg) Height (centimeters-cm) Weight and height will be combined to calculate BMI in Kg/m^2	12 months
Clinically relevant changes in CT/MRI	only if clinically indicated	12 months
Atrial Arrythmias (AA) burden and vascular stiffness (measured by a measuring bracelet)	AA burden and vascular stiffness measured by the measuring bracelet	12 months
Cognitive function test (MoCA)	evaluation of cognitive function (includes different tasks: visual/executive; naming; memory; attention; language; abstraction; delayed recall; orientation). Total score will be calculated and collected.	Baseline and Follow up at 12 months
EQ-5D-5L Quality of Life questionnaire	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.	Baseline and Follow up at 12 months
Ischaemic events (systemic, myocardial and cerebral)	ischaemic events	12 months
Echo analysis (TEE_transesophageal echocardiography): LAA smoke available	collected as Yes/No	12 months
Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA	measured in cm/sec	12 months
Echo analysis (TEE_transesophageal echocardiography): Antrum diameter	measured in mm	12 months
Echo analysis (TTE_transthoracic echocardiography): LVEF	Measured in %; Biplane Simpson Method	12 months
Echo analysis (TTE_transthoracic echocardiography): LA diameter	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).	12 months
Echo analysis (TTE_transthoracic echocardiography): LA volume	measured in mL	12 months
Echo analysis (TTE_transthoracic echocardiography): Septum thickness	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).	12 months
Echo analysis (TTE_transthoracic echocardiography): Degree of mitral valve insufficiency	Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None	12 months
Echo analysis (TTE_transthoracic echocardiography): Degree of tricuspid valve insufficiency	Grade I/trivial; Grade II/moderate; Grade III/moderate to severe; Grade IV/severe; None	12 months
ECG analysis	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).	12 months
MRI analysis: LAEF	Left atrial ejection fractio measured in %	12 months
MRI analysis: LAVi	LAVi left atrial volume index measured in ml/m^2	12 months
MRI analysis: LALRS	LALRS left atrial longitudinal reservoir strain measured in %	12 months
MRI analysis: LALBS	LALBS left atrial longitudinal booster strain measured in %	12 months
CT scan analysis	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT scan: Atriomic risk for AF	5 year event risk: Yes/No	12 months
CT scan: Epicardial Adipose tissue volume	measured in cm^3	12 months
CT scan: Epicardial adipose tissue mean attenuation	measured in HU	12 months
CT scan: Left atrium volume	measured in cm^3	12 months

Collaborators and Investigators

• Sponsor: Atrial Fibrillation Network
• Investigators: Study Director: Stéphan Hatem, Prof, ICAN Nutrition Education and Research

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: MAESTRIA-AFNET10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No