Clinical Cohorts for Validation of New Digital Biomarkers

Atrial Fibrillation Clinical Trial

— MAESTRIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855538
• Other study ID #: MAESTRIA-AFNET10
• Status: Recruiting
• Start date: March 2, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2023
• Source: Atrial Fibrillation Network
• Contact: Andreas Götte, Prof
• Phone: +49 05251/86-1651
• Email: Andreas.Goette[@]vincenz.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	St Vincenz Hospital	Paderborn

Sponsors (1)

Lead Sponsor	Collaborator
Atrial Fibrillation Network

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical examination	Weight (Kilograms-Kg) Height (centimeters-cm) Weight and height will be combined to calculate BMI in Kg/m^2	12 months
Primary	Clinically relevant changes in CT/MRI	only if clinically indicated	12 months
Primary	Atrial Arrythmias (AA) burden and vascular stiffness (measured by a measuring bracelet)	AA burden and vascular stiffness measured by the measuring bracelet	12 months
Primary	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
Primary	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
Primary	Ischaemic events (systemic, myocardial and cerebral)	ischaemic events	12 months
Primary	Echo analysis (TEE_transesophageal echocardiography): LAA smoke available	collected as Yes/No	12 months
Primary	Echo analysis (TEE_transesophageal echocardiography): Flow velocity in LAA	measured in cm/sec	12 months
Primary	Echo analysis (TEE_transesophageal echocardiography): Antrum diameter	measured in mm	12 months
Primary	Echo analysis (TTE_transthoracic echocardiography): LVEF	Measured in %; Biplane Simpson Method	12 months
Primary	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
Primary	Echo analysis (TTE_transthoracic echocardiography): LA volume	measured in mL	12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	MRI analysis: LAEF	Left atrial ejection fractio measured in %	12 months
Primary	MRI analysis: LAVi	LAVi left atrial volume index measured in ml/m^2	12 months
Primary	MRI analysis: LALRS	LALRS left atrial longitudinal reservoir strain measured in %	12 months
Primary	MRI analysis: LALBS	LALBS left atrial longitudinal booster strain measured in %	12 months
Primary	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	CT scan: Atriomic risk for AF	5 year event risk: Yes/No	12 months
Secondary	CT scan: Epicardial Adipose tissue volume	measured in cm^3	12 months
Secondary	CT scan: Epicardial adipose tissue mean attenuation	measured in HU	12 months
Secondary	CT scan: Left atrium volume	measured in cm^3	12 months