Non-Invasive diagnostics of atrial cardiomyopathy and prevalence of ischemic cerebral embolism in patients with atrial fibrillation

Non-Invasive diagnostics of atrial cardiomyopathy and prevalence of ischemic cerebral embolism in patients with atrial fibrillation - NICE-AF-Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00029987

Enrollment

935

Registered

2023-10-23

Start date

2023-11-28

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48.9 I64

Interventions

Group 1: Performance of both a cerebral MRI to diagnose and quantify silent cerebral lesions and a duplex sonography to diagnose cerebrovascular atherosclerosis in atrial fibrillation patients without

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: - Male and female patients aged =18 years and <90 years with atrial fibrillation diagnosis - Written informed consent for study participation prior to enrollment

Exclusion criteria

Exclusion criteria: - Prior cardiac surgery or left atrial catheter ablation - Contra-indications for MRI e.g. claustrophobia, carriage of metal implants, non-MRI conditional cardiac or other devices - No sinus rhythm during the hospital stay to perform ECG or transthoracic echocardiography in sinus rhythm - Short life expectancy due to comorbid conditions - Heart failure, NYHA 4 - Severe valvular heart disease (mitral or aortic valvulopathy >Grade 2/3) - Other major disabling disease - Acute inflammatory or infectious disease - Body mass index (BMI): =18.0 and = 36.0 kg/m²

Design outcomes

Primary

Measure	Time frame
Detection of at least 10% difference regarding the prevalence of silent cerebral lesions (SCL) between patients with ACM and without ACM assessed by the amplified P-wave analysis (aPWA)	—

Secondary

Measure	Time frame
• Assessment of the prevalence of SCL between patients with ACM and without ACM assessed by the amplified P-wave analysis (aPWA). • Assessment of the prevalence of SCL between patients with ACM and without ACM assessed by echocardiography parameters which characterize atrial function (left atrial emptying fraction (LA-EF), left atrial strain (LAS)), and CHA2DS2-VASc-score. • Comparison of the prevalence of SCL between patients with ACM and without ACM assessed by the amplified P-wave analysis (aPWA) vs established ECG-markers (standard P-wave duration, P-terminal force in V1, P-terminal duration in V1, P-terminal amplitude in V1), and assessed by echocardiography parameters which characterize atrial function (left atrial emptying fraction (LA-EF), left atrial strain (LAS)) vs established echocardiography markers (left atrial diameter, left atrial volume index, pulmonary artery pressure, E/A, deceleration time, septal e´, E/e´, functional mitral regurgitation). • Prevalence of cerebrovascular atherosclerosis assessed by duplex sonography using the non-invasive diagnostic tools for ACM diagnosis. • Assessment of the prevalence of SCL between patients with ACM and without ACM assessed by invasively measured low-voltage areas and left atrial activation time measured in electroanatomical mapping in patients undergoing pulmonary vein isolation. • Evaluation of heart volumetry in cardiac MRI in addition to cerebral MRI in a subgroup of patients undergoing pulmonary vein isolation between patients with ACM and without ACM.	—

Measure

Time frame

• Assessment of the prevalence of SCL between patients with ACM and without ACM assessed by the amplified P-wave analysis (aPWA). • Assessment of the prevalence of SCL between patients with ACM and without ACM assessed by echocardiography parameters which characterize atrial function (left atrial emptying fraction (LA-EF), left atrial strain (LAS)), and CHA2DS2-VASc-score. • Comparison of the prevalence of SCL between patients with ACM and without ACM assessed by the amplified P-wave analysis (aPWA) vs established ECG-markers (standard P-wave duration, P-terminal force in V1, P-terminal duration in V1, P-terminal amplitude in V1), and assessed by echocardiography parameters which characterize atrial function (left atrial emptying fraction (LA-EF), left atrial strain (LAS)) vs established echocardiography markers (left atrial diameter, left atrial volume index, pulmonary artery pressure, E/A, deceleration time, septal e´, E/e´, functional mitral regurgitation). • Prevalence of cerebrovascular atherosclerosis assessed by duplex sonography using the non-invasive diagnostic tools for ACM diagnosis. • Assessment of the prevalence of SCL between patients with ACM and without ACM assessed by invasively measured low-voltage areas and left atrial activation time measured in electroanatomical mapping in patients undergoing pulmonary vein isolation. • Evaluation of heart volumetry in cardiac MRI in addition to cerebral MRI in a subgroup of patients undergoing pulmonary vein isolation between patients with ACM and without ACM.

—

Countries

Germany

Contacts

Public ContactMartin Eichenlaub

Uniklinik Freiburg, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Klinik für Kardiologie und Angiologie

martin.eichenlaub@uniklinik-freiburg.de004976334020

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026