Risk StratificationNCT06011590
QRS Microfragmentation in ECG as Predictor of Mortality and Morbidity - a Retrospective Analysis
An observational study of Risk Stratification, run by Medical University Innsbruck.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Stratification
- How many people
- 150,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Insuffizient ECG Recording quality
About this study
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.
- Conditions
- Risk Stratification
- Being tested
- No intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Death of any cause
Measured: between 01.01.2000 and 31.07.2022
Secondary outcomes (2)
Hospitalization
Unplanned Hospitalization
Measured: between 01.01.2000 and 31.07.2022
Lenght of hospital stay
Lenght of hospital stay
Measured: between 01.01.2000 and 31.07.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jan 2000
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk StratificationStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011590
- Sponsor's protocol ID
- 1244/2022
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon reasonable request and after concluding all legal and ethic formalities.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QRS Microfragmentation in ECG as Predictor of Mortality and Morbidity - a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06011590
- Acronym / sponsor ID
- 1244/2022
- Conditions
- Risk Stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150,000 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: No intervention.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Insuffizient ECG Recording quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention.No intervention. | Other | Study Cohort |
Primary outcome
All cause mortality
Time frame: between 01.01.2000 and 31.07.2022
Death of any cause
2 secondary outcomes
Hospitalization
Time frame: between 01.01.2000 and 31.07.2022
Lenght of hospital stay
Time frame: between 01.01.2000 and 31.07.2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon reasonable request and after concluding all legal and ethic formalities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Stratification, run by Medical University Innsbruck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: between 01.01.2000 and 31.07.2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.