NCT02128477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
754

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

6.2 years

First QC Date

February 5, 2014

Last Update Submit

January 24, 2017

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionRepolarization instabilityVentricular fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of total deaths

    24 months

Secondary Outcomes (1)

  • Number of cardiovascular deaths

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

myocardial infarction

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eberhard-Karls-University Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Myocardial InfarctionVentricular Fibrillation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, Cardiac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

May 1, 2014

Study Start

October 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

DE(1)