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

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.

Study Overview

• Status: Completed
• Conditions: Risk Stratification
• Intervention / Treatment: Other: No intervention.

• Study Type: Observational
• Enrollment (Actual): 150000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Death of any cause	between 01.01.2000 and 31.07.2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Unplanned Hospitalization	between 01.01.2000 and 31.07.2022
Lenght of hospital stay	Lenght of hospital stay	between 01.01.2000 and 31.07.2022

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1244/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared upon reasonable request and after concluding all legal and ethic formalities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No