on-Invasive diagnostics of atrial cardiomyopathy and prevalence of ischemic cerebral embolism in patients with atrial fibrillatio

Phase 4

Recruiting

• Conditions: I48.9; I64; Atrial fibrillation and atrial flutter, unspecified; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00029987
• Lead Sponsor: niklinik Freiburg, Universitäts-Herzzentrum Freiburg-Bad Krozingen - Klinik für Kardiologie und Angiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 935

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)