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NCT04963218 · ClinicalTrials.gov registry record
A Multi-Center Study of Detection of Low Ventricular Ejection Fraction
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 16,000
- Enrollment target
NCT04963218: Completed study, sponsored by Mayo Clinic.
NCT04963218 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 16,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04963218 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 16,000 participants
- Enrollment target
Study Summary
This is a multi-site, retrospective study to evaluate the performance of a locked AI-based algorithm for detection of left ventricular systolic dysfunction. A prerequisite for inclusion of subjects from each institution will be the availability of at least one digital 12-lead ECG paired with an echocardiogram with LVEF information within 30 days of the date of the ECG. The AI-ECG LVSD algorithm will be applied on all ECGs and diagnostic performance features for the detection of LVSD will be estimated using the provided paired LVEF value (Low LVEF as the reference label). Performance will also be assessed in subgroups of subjects determined by demographic and clinical factors.
Primary Outcome
Number of participants with presence of EF less than of equal to 40% identified by 12-lead AI ECG algorithm
Interventions
- DIAGNOSTIC_TEST AI Algorithm to detect LVEF in ECG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16,000 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2022-04-13 |
What the finished NCT04963218 record still lists
NCT04963218 is an observational study that tracks outcomes without assigning an intervention. Its 16,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which AI Algorithm to detect LVEF in ECG is the first listed.
NCT04963218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04963218 about?
NCT04963218 is a clinical study titled "A Multi-Center Study of Detection of Low Ventricular Ejection Fraction". This is a multi-site, retrospective study to evaluate the performance of a locked AI-based algorithm for detection of left ventricular systolic dysfunction. A prerequisite for inclusion of subjects from each institution will be the availability of at least one digital 12-lead ECG paired with an echo...
What is the current status of trial NCT04963218?
This trial is currently completed. The enrollment target is 16,000 participants. The study started on 2021-08-30. Estimated completion is 2022-04-13.
What interventions are being tested in trial NCT04963218?
The interventions under investigation include: AI Algorithm to detect LVEF in ECG (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04963218?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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