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NCT06183294 · ClinicalTrials.gov registry record
Evaluation of a Novel Non-Invasive Automated Fractional Flow Reserve Software System in Patients With Coronary Artery Disease
A clinical trial, sponsored by University of California, San Diego.
- Completed
- Registry status
- 100
- Enrollment target
NCT06183294 is a clinical trial that has completed, run by University of California, San Diego. The registered enrollment target is 100 participants.
The verdict
NCT06183294 has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
This retrospective study will evaluate the coronary angiograms of approximately 100 patients who have undergone invasive angiography and fractional flow reserve (FFR). DICOM files of the angiograms will be analyzed on a secure computer within the cardiac catheterization laboratory using the AutocathFFR software to assess if invasive FFR measurements and automated computer analysis of FFR measurements correlate. AutocathFFR measurement per lesion will be compared to the gold standard, invasive FFR value, where an FFR ≤ 0.80 will be considered "positive", while an FFR \> 0.8 will be considered "negative". The AutocathFFR value will be compared to the invasive FFR measurements. The sensitivity and specificity of the AutocathFFR will be calculated, as well as the AutocathFFR accuracy, positive predictive value and negative predictive value per lesion. Device success will be calculated as the ratio of completed versus initiated AutocathFFR index calculations. Usability of the AutocathFFR software will be evaluated using dedicated questionnaires to be completed by the user (cardiologists).
Interventions
- OTHER Collecting invasive FFR measurements.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2024-01-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06183294
The ClinicalTrials.gov registry entry for NCT06183294 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Collecting invasive FFR measurements. is the first listed.
NCT06183294 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06183294 about?
NCT06183294 is a clinical study titled "Evaluation of a Novel Non-Invasive Automated Fractional Flow Reserve Software System in Patients With Coronary Artery Disease". This retrospective study will evaluate the coronary angiograms of approximately 100 patients who have undergone invasive angiography and fractional flow reserve (FFR). DICOM files of the angiograms will be analyzed on a secure computer within the cardiac catheterization laboratory using the Autocath...
What is the current status of trial NCT06183294?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2023-08-22. Estimated completion is 2024-01-04.
What interventions are being tested in trial NCT06183294?
The interventions under investigation include: Collecting invasive FFR measurements. (OTHER).
Who is sponsoring clinical trial NCT06183294?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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