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NCT03800862 · ClinicalTrials.gov registry record
The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain
A clinical trial, sponsored by Lancaster General Hospital.
- Terminated
- Registry status
- 14
- Enrollment target
NCT03800862: Clinical Trial study, sponsored by Lancaster General Hospital.
NCT03800862 is a clinical trial that was terminated before completion, run by Lancaster General Hospital. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03800862 was terminated before completion, sponsored by Lancaster General Hospital.
- TERMINATED
- Registry status
- 14 participants
- Enrollment target
Study Summary
This is a prospective, observational study designed to evaluate the role of dynamic computed tomographic perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) in patients presenting with chest discomfort.Patients with lesions greater than 50% and who meet all other inclusion/exclusion criteria will qualify to be a subject in the CTP study /CT-FFR 49. Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion. If patients are deemed to be appropriate for invasive angiography by the referring physician, coronary lesions between 40% and 80% will get a fractional flow measurement performed if indicated on a clinical basis. Stenosis in vessels less than 1.5 mm will be excluded from the study. The CT-FFR and CTP will be performed in these patients within 60 days of index coronary angiography.
Primary Outcome
Performance of CT-FFR compared to CTP for each vessel assessed, as per the below common suite of measures: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, discrimination
Interventions
- DEVICE CT-FFR and CTP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2022-10-27 |
Why NCT03800862 stopped before completion
NCT03800862 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which CT-FFR and CTP is the first listed.
NCT03800862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03800862 about?
NCT03800862 is a clinical study titled "The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain". This is a prospective, observational study designed to evaluate the role of dynamic computed tomographic perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) in patients presenting with chest discomfort.Patients with lesions greater than 50% and who meet all other inclusi...
What is the current status of trial NCT03800862?
This trial is currently terminated. The enrollment target is 14 participants. The study started on 2019-03-27. Estimated completion is 2022-10-27.
What interventions are being tested in trial NCT03800862?
The interventions under investigation include: CT-FFR and CTP (DEVICE).
Who is sponsoring clinical trial NCT03800862?
This trial is sponsored by Lancaster General Hospital, which has 15 total clinical trials registered on ClinicalTrials.gov.
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