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NCT02538861 · ClinicalTrials.gov registry record
Acute Chest Pain Imaging in the ED With the Combine CCTA and CT Perfusion
A clinical trial, sponsored by Baptist Health South Florida.
- Completed
- Registry status
- 250
- Enrollment target
NCT02538861 is a clinical trial that has completed, run by Baptist Health South Florida. The registered enrollment target is 250 participants.
The verdict
NCT02538861 has completed, sponsored by Baptist Health South Florida.
- COMPLETED
- Registry status
- 250 participants
- Enrollment target
Study Summary
This is a prospective open label two arms clinical trial. ARM-A patients will receive the standard of care diagnostic test at Baptist Hospital Main (BHM), which includes Single Photon Emission Computed Tomography (SPECT) imaging, while ARM-B patients will be randomized sequentially into two groups; Group-1 will receive CT Angiography and CT myocardial perfusion with new Revolution CT scanner (General Electric Healthcare) while the Group-2 will receive SPECT imaging test; both groups of ARM-B at West Kendall Baptist Hospital (WKBH). The primary hypothesis is that the combined evaluation of CT angiography with CT myocardial perfusion is more efficient in detecting or excluding acute coronary syndrome resulting in early discharge and decrease length of stay of patients from the Emergency Department (ED) compared to a strategy with SPECT alone. The secondary hypothesis is that a strategy with CTA/CTP can reduce direct patient care costs and potentially improve patient outcomes in the same patient population when compared to a strategy with SPECT imaging alone. The main purpose of this study is to have a definite ED chest pain admission triage, which will help to reduce the length of stay and direct patient cost. This approach will reduce the economic burden in intermediate risk group patients as well. We had a Baptist statistician run the numbers. This study will provide important preliminary data to guide clinical implementation of CTP/CTA in clinical practice. We divided arm B into two groups as the CT protocol might be different at each hospital, so we want to reduce bias as a result of variation in clinical patterns in the different hospitals. Also, we kept 50 patients in arm A (Baptist hospital) to have a control group at the hospital level.
Interventions
- DIAGNOSTIC_TEST SPECT Imaging Test at Baptist hospital
- DIAGNOSTIC_TEST CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital
- DIAGNOSTIC_TEST SPECT Imaging Test at West Kendall Baptist Hospital
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-06-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02538861
The ClinicalTrials.gov registry entry for NCT02538861 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baptist Health South Florida, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which SPECT Imaging Test at Baptist hospital is the first listed.
NCT02538861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02538861 about?
NCT02538861 is a clinical study titled "Acute Chest Pain Imaging in the ED With the Combine CCTA and CT Perfusion". This is a prospective open label two arms clinical trial. ARM-A patients will receive the standard of care diagnostic test at Baptist Hospital Main (BHM), which includes Single Photon Emission Computed Tomography (SPECT) imaging, while ARM-B patients will be randomized sequentially into two groups; ...
What is the current status of trial NCT02538861?
This trial is currently completed. The enrollment target is 250 participants. The study started on 2015-09. Estimated completion is 2019-06-06.
What interventions are being tested in trial NCT02538861?
The interventions under investigation include: SPECT Imaging Test at Baptist hospital (DIAGNOSTIC_TEST), CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital (DIAGNOSTIC_TEST), SPECT Imaging Test at West Kendall Baptist Hospital (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02538861?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
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