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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
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Baptist Health South Florida

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Direct patient costs [ Time Frame: First 24 to 72 hours ]
    Direct patient costs will be measured in both study arms



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is > 35 years of age.
  2. The patient had an episode of chest pain at rest or during exercise within the previous 24 hours.
  3. The patient is classified as "Level 3" in the 5-Level Miami Baptist Chest Pain Protocol (Cury R et al. AJR, 2012; 200: 57-65) (44) or The patient is classified as "Level 4" in the 5-Level Miami Baptist Chest Pain Protocol, and has either a 40-70% stenosis by coronary CT angiography, an Agatston Calcium Score >400, or non-evaluable segments in coronary CT angiography due to calcifications, motion artifacts, or other technical reasons. (Level 4 patients who have already been scan for CTA; will not have to repeat the CTA. Eligible Level 4 patients will only go for CT Myocardial Perfusion scan.
  4. Women of childbearing potential have a negative pregnancy urine or serum test.
  5. The patient understands the study requirements and procedures and provides written informed consent using a form that has been approved by the Institutional Review Board (IRB) before any study specific test or procedures are performed.
  6. The patient is willing to comply with the specified follow-up telephone call.

Exclusion Criteria:

  1. The patient is classified as "Level 1", "Level 2", or "Level 5" in the 5-Level Miami Baptist Chest Pain Protocol (Cury R et al. AJR, 2012; 200: 57-65). This includes patients with STEMI (Level-1), NSTEMI or Unstable Angina (Level-2) and non-cardiac chest pain patients (Level-5)
  2. Known allergy to iodinated contrast agent or creatinine >1.5mmol/L.
  3. Atrial Fibrillation, Flutter or irregular heart rhythm.
  4. Known history of severe asthma.
  5. Body Mass Index (BMI) >45.
  6. Patients in unstable conditions.

Information from the National Library of Medicine

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


Contacts
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Contact: Jacqueline Mejias, CCRC (786) 467-2539 JacquieM@baptisthealth.net
Contact: Gowtham Grandhi, MD (786) 596-5917 gowthamg@baptisthealth.net

Locations
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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         
Sponsors and Collaborators
Baptist Health South Florida
GE Healthcare
Investigators
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Principal Investigator: Ricardo C Cury, MD Baptist Health South Florida

Publications of Results:

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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT02538861     History of Changes
Other Study ID Numbers: IRB#15-062
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms