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Completed

NCT Number: NCT02128477

Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients

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.

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Key information

Conditions

Myocardial Infarction Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eberhard-Karls-University Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of total deaths

    Time frame: 24 months

Secondary outcomes

  1. Number of cardiovascular deaths

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Thebiosignals.com

Other

Registry information

Official study title

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

Acronym: PRD-MI

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 1, 2014
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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