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NCT02128477 Clinical Trial

Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients

Myocardial Infarction Clinical Trial

— PRD-MI  

Official title:
Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients: Validation Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02128477
Other study ID # BIO012014
Secondary ID
Status Completed
Phase N/A
First received February 5, 2014
Last updated January 24, 2017
Start date October 2010
Est. completion date December 2016

Study information
Verified date January 2017
Source Thebiosignals.com
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 754
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Eberhard-Karls-University Tuebingen Tuebingen Baden-Württemberg

Sponsors (1)
Lead Sponsor Collaborator
Thebiosignals.com

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of total deaths 24 months
Secondary Number of cardiovascular deaths 24 months
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