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Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients (PRD-MI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02128477
First Posted: May 1, 2014
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thebiosignals.com
  Purpose
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.

Condition
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients: Validation Study

Resource links provided by NLM:


Further study details as provided by Thebiosignals.com:

Primary Outcome Measures:
  • Number of total deaths [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Number of cardiovascular deaths [ Time Frame: 24 months ]

Enrollment: 754
Actual Study Start Date: October 2010
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
myocardial infarction
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128477


Locations
Germany
Eberhard-Karls-University Tuebingen
Tuebingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
Thebiosignals.com
  More Information

Responsible Party: Thebiosignals.com
ClinicalTrials.gov Identifier: NCT02128477     History of Changes
Other Study ID Numbers: BIO012014
First Submitted: February 5, 2014
First Posted: May 1, 2014
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Thebiosignals.com:
Myocardial infarction
Repolarization instability
Ventricular fibrillation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases