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QRS Microfragmentation in ECG as Predictor of Mortality and Morbidity - a Retrospective Analysis

Sponsor
Medical University Innsbruck (Other)
Overall Status
Completed
CT.gov ID
NCT06011590
Collaborator
(none)
150,000
Enrollment
270.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Over the past decades, several ECG-based parameters have been identified as independent predictors of worsened prognosis in affected patients. In addition to visual assessment of morphology, methods of computer-based machine ECG analysis have gained importance in recent years. These methods allow the detection of systemic abnormalities in ECGs that are not visible to the naked eye. An example of this is provided by the so-called "QRS microfragmentations".

The aim of this evaluation is to retrospectively collect all established as well as new quantitative and qualitative ECG parameters (such as QRS microfragmentation) in a large patient collective. Subsequently, after characterization of the patients, an independent multivariate risk prediction model should be developed based on computer-based ECG analysis using maschnine learning algorithms.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention.

Study Design

Study Type:
Observational
Actual Enrollment :
150000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
QRS Microfragmentation in ECG as Predictor of Mortality and Morbidity - a Retrospective Analysis
Actual Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Jul 31, 2022
Actual Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Study Cohort

All patients treated at the Department of Internal Medicine at the Medical University of Innsbruck between 01.01.2000 and 31.07.2022, in whom a 10 second 12-lead ECG is available from clinical routine.

Other: No intervention.
No intervention.

Outcome Measures

Primary Outcome Measures

  1. All cause mortality [between 01.01.2000 and 31.07.2022]

    Death of any cause

Secondary Outcome Measures

  1. Hospitalization [between 01.01.2000 and 31.07.2022]

    Unplanned Hospitalization

  2. Lenght of hospital stay [between 01.01.2000 and 31.07.2022]

    Lenght of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patients who presented to the Department of Internal Medicine at the Medical University in Innsbruck between 01.01.2000 and 31.07.2022 and received an ECG recording as part of routine clinical practice.

  • Age ≥ 18 years

  • Residence in Austria

Exclusion Criteria:
  • Insuffizient ECG Recording quality

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT06011590
Other Study ID Numbers:
  • 1244/2022
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 25, 2023