Acute Chest Pain Imaging in the ED With the Combine CCTA and CT Perfusion
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|ClinicalTrials.gov Identifier: NCT02538861|
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain||Radiation: SPECT Imaging Test at Baptist hospital Radiation: CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital Radiation: SPECT Imaging Test at West Kendall Baptist Hospital||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute Chest Pain Imaging in Emergency Department With Combined Approach of Coronary CT Angiography and CT Myocardial Perfusion|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: ARM-A
Arm-A patients will receive the standard of care diagnostic test at Baptist Hospital, which includes SPECT imaging
Radiation: SPECT Imaging Test at Baptist hospital
Single Photon Emission Tomography (SPECT) testing at Baptist Hospital.
Active Comparator: ARM-B (Group-1)
Group-1 will receive CT Angiography and CT myocardial perfusion with new Revolution CT scanner.
Radiation: CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital
The combined approach of CT Angiography and CT myocardial perfusion with new Revolution CT scanner
Active Comparator: ARM-B (Group-2)
The Group-2 of arm B will receive SPECT imaging test.
Radiation: SPECT Imaging Test at West Kendall Baptist Hospital
Single Photon Emission Tomography (SPECT) testing at West Kendall Baptist hospital.
- Length of stay [ Time Frame: First 24 to 72 hours ]The average length of stay will be calculated in both study arms. Currently patients have 24 hours of stay at hospital in the chest pain observation unit. We expect and propose that with this new study the length of stay will be reduce to less than 14 hours.
- Direct patient costs [ Time Frame: First 24 to 72 hours ]Direct patient costs will be measured in both study arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538861
|Contact: Jacqueline Mejias, CCRC||(786) 467-2539||JacquieM@baptisthealth.net|
|Contact: Gowtham Grandhi, MD||(786) email@example.com|
|United States, Florida|
|Baptist Hospital of Miami||Recruiting|
|Miami, Florida, United States, 33176|
|Contact: Ricardo Cury, MD|
|West Kendall Baptist Hospital||Recruiting|
|Miami, Florida, United States, 33196|
|Contact: Ricardo Cury, MD|
|Principal Investigator:||Ricardo C Cury, MD||Baptist Health South Florida|