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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Thebiosignals.com
Sponsor:
Information provided by (Responsible Party):
Thebiosignals.com
ClinicalTrials.gov Identifier:
NCT02128477
First received: February 5, 2014
Last updated: April 29, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of cardiovascular deaths [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: October 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128477

Contacts
Contact: Axel Bauer, MD +49 7071 29 82922 bauer.de@googlemail.com
Contact: Christine Zuern, MD +49 7071 29 83153 christine.zuern@med.uni-tuebingen.de

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

No publications provided

Responsible Party: Thebiosignals.com
ClinicalTrials.gov Identifier: NCT02128477     History of Changes
Other Study ID Numbers: BIO012014
Study First Received: February 5, 2014
Last Updated: April 29, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 18, 2014