P-wave Analysis for Risk Evaluation of Ischemic Cerebral Embolism in Patients with Left Atrial Fibrosis- A Prospective Observational

Not Applicable

Recruiting

• Conditions: Atrial fibrillation and flutter; I48; Cerebral infarction; I63

• Registration Number: DRKS00030397
• Lead Sponsor: niversitätsklinikum FreiburgCampus Bad Krozingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Male and female patients aged =50 years and <85 years
- Digital amplified 12-Lead-ECG available in normal sinus rhythm
- 12-leads ECG recorded as part of the admission examination in all patients admitted to our center will be scrutinized regarding p-wave duration
- Written informed consent for study participation prior to enrollment

Exclusion Criteria

- Prior cardiac surgery
- Known atrial fibrillation, atrial flutter or atrial tachycardia
- Current clinical indication for oral anticoagulant therapy
- Prior catheter ablation for atrial fibrillation, atrial flutter or atrial tachycardia within the right and/or left atrium
- Patients with implanted cardiac devices / pacemaker / ICD
- Contra-indications for cerebral MRI like e.g. claustrophobia, carriage of metal implants
- 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
- Female patients of child-bearing potential

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the current pilot study is to assess the prevalence and incidence of stroke and silent cerebral infarcts by MRI at study inclusion and at 18 and 36 months FU in patients without and with electrocardiographic evidence of FAM (fibrotic atrial cardio-myopathy).

Secondary Outcome Measures

Name	Time	Method
•Evaluation of the rate of clinically overt ischemic stroke/transient ischemic attack or new cerebral infarcts by MRI during the 18- and/or 36-months follow-up period in patients with vs without FAM (based on APWA)<br>- Evaluation of Incidence of new-onset atrial fibrillation or flutter.