CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
SPECT Imaging Test at Baptist hospital +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02538861
NCT02538861N/ACompleted

Acute Chest Pain Imaging in Emergency Department With Combined Approach of Coronary CT Angiography and CT Myocardial Perfusion

Baptist Health South Florida·observational·Posted Sep 2, 2015·Updated Apr 20, 2022

In Brief

An observational study evaluating SPECT Imaging Test at Baptist hospital, CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital, and 1 other intervention for Chest Pain. Completed, enrolled 250 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChest Pain
CountriesUnited States
CollaboratorsGE Healthcare

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2, 2015
Enrollment StartSep 1, 2015
Primary CompletionJun 6, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.8 years ago

Interventions

SPECT Imaging Test at Baptist hospitalother

Single Photon Emission Tomography (SPECT) testing at Baptist Hospital.

CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospitalother

The combined approach of CT Angiography and CT myocardial perfusion with new Revolution CT scanner

SPECT Imaging Test at West Kendall Baptist Hospitalother

Single Photon Emission Tomography (SPECT) testing at West Kendall Baptist hospital.