NCT06011590

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

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

January 1, 2000

Completed
22.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

22.6 years

First QC Date

August 21, 2023

Last Update Submit

August 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Death of any cause

    between 01.01.2000 and 31.07.2022

Secondary Outcomes (2)

  • Hospitalization

    between 01.01.2000 and 31.07.2022

  • Lenght of hospital stay

    between 01.01.2000 and 31.07.2022

Study Arms (1)

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.

Interventions

No intervention.

Study Cohort

Eligibility Criteria

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

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.

You may qualify if:

  • 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

You may not qualify if:

  • Insuffizient ECG Recording quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

January 1, 2000

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

August 25, 2023

Record last verified: 2023-08