Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).

Conditions

Interventions

  • Standard Care Behavioral
    Intervention Desc: Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
    ARM 1: Kind: Experimental
    Label: standard care
    Description: Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
  • Prolonged ECG monitoring Other
    Intervention Desc: 10-day Holter ECG measurement
    ARM 1: Kind: Experimental
    Label: prolonged ECG monitoring
    Description: Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary number of atrial fibrillation/flutter 30 month after study start No
Secondary number of atrial fibrillation (/flutter) within 12 months 24 months after study start No
Secondary number of atrial fibrillation (/flutter) without hospitalisation 30 months after study start No
Secondary number of recurrent stroke or systemic embolism 24 months after study start No
Secondary total mortality 24 months after study start No
Secondary number of cardiovascular deaths 24 months after study start No
Secondary number of cerebrovascular deaths 24 months after study start No
Secondary number of transient ischemic attacks 24 months after study start No
Secondary number of myocardial infarctions 24 months after study start No
Secondary number of bleeding complications 24 months after study start No
Secondary quality of life 24 months after study start No
Secondary number of atrial fibrillation (/flutter) in extended monitoring period 24 months after study start No
Secondary costs 24 months after study start No
Secondary number of correct monitorings 24 months after study start No
Secondary number of atrial fibrillation (/flutter) within 12 months after patient's inclusion 24 months after study start No

Sponsors