Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT02128477
• Lead Sponsor: Thebiosignals.com

Brief Summary

Increased periodic repolarization dynamics (PRD) indicate increased risk of death in cardiac patients. This study thoughts to prospectively validate the prognostic value of PRD in post-infarction patients.

Detailed Description

Periodic repolarization dynamics (PRD) reflect periodic changes of repolarization instability located in the low-frequency spectral range. Level of PRD can be assessed using a high resolution surface ECG recorded in the 12-leads of Frank leads configuration during resting conditions.

Increased levels of PRD have been associated with sympathetic overactivity and increased risk of mortality in survivors of acute myocardial infarction and patients undergoing a clinically indicated exercise test.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 754

Inclusion Criteria

• previous myocardial infarction >4 weeks
• age >18 years

Exclusion Criteria

• life expectancy < 1 year due to non-cardiac causes
• unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of total deaths	24 months

Secondary Outcome Measures

Name	Time	Method
Number of cardiovascular deaths	24 months

Trial Locations

Locations (1)

Eberhard-Karls-University Tuebingen; 🇩🇪 Tuebingen, Baden-Württemberg, Germany