Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by University of California, San Diego.
NCT06183294 is a clinical trial that has completed, run by University of California, San Diego. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The software device will be run on angiograms generated during cardiac catheterization and will be compared to the gold standard, invasive fractional flow reserve (FFR) measurements.
Interventions
- OTHER Collecting invasive FFR measurements.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2024-01-04 |
What the finished NCT06183294 record still lists
NCT06183294 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Collecting invasive FFR measurements. is the first listed.
NCT06183294 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI