Clinical Cohorts for Validation of New Digital Biomarkers

NCT05855538 | Unknown

• 1 other identifier: MAESTRIA-AFNET10
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (4)

• CT scan: Atriomic risk for AF

  12 months

• CT scan: Epicardial Adipose tissue volume

  12 months

• CT scan: Epicardial adipose tissue mean attenuation

  12 months

• CT scan: Left atrium volume

  12 months

Study Arms (3)

Paroxysmal AF

200 patients

Persistent AF

200 patients

Permanent AF

200 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atrial Fibrillation Network: lead

Study Sites (1)

St Vincenz Hospital

Paderborn, 33098, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

optional extra blood for MAESTRIA Biobank

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphan Hatem, Prof

  ICAN Nutrition Education and Research

  STUDY DIRECTOR

Central Study Contacts

Andreas Götte, Prof

CONTACT

+49 05251/86-1651; Andreas.Goette@vincenz.de

Beatriz Lorente Cánovas, Dr

CONTACT

+49 251 980 1332; beatriz.lorente@af-net.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 11, 2023
• Study Start: March 2, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

DE (1)