Chest Pain Clinical Trial
Official title:
Acute Chest Pain Imaging in Emergency Department With Combined Approach of Coronary CT Angiography and CT Myocardial Perfusion
NCT number | NCT02538861 |
Other study ID # | IRB#15-062 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | June 6, 2019 |
Verified date | April 2022 |
Source | Baptist Health South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | June 6, 2019 |
Est. primary completion date | June 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Baptist Hospital of Miami | Miami | Florida |
United States | West Kendall Baptist Hospital | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Baptist Health South Florida | GE Healthcare |
United States,
Cury RC, Feuchtner GM, Batlle JC, Peña CS, Janowitz W, Katzen BT, Ziffer JA. Triage of patients presenting with chest pain to the emergency department: implementation of coronary CT angiography in a large urban health care system. AJR Am J Roentgenol. 201 — View Citation
Cury RC, Nieman K, Shapiro MD, Butler J, Nomura CH, Ferencik M, Hoffmann U, Abbara S, Jassal DS, Yasuda T, Gold HK, Jang IK, Brady TJ. Comprehensive assessment of myocardial perfusion defects, regional wall motion, and left ventricular function by using 6 — View Citation
Gerber BL, Rochitte CE, Melin JA, McVeigh ER, Bluemke DA, Wu KC, Becker LC, Lima JA. Microvascular obstruction and left ventricular remodeling early after acute myocardial infarction. Circulation. 2000 Jun 13;101(23):2734-41. — View Citation
Habis M, Capderou A, Ghostine S, Daoud B, Caussin C, Riou JY, Brenot P, Angel CY, Lancelin B, Paul JF. Acute myocardial infarction early viability assessment by 64-slice computed tomography immediately after coronary angiography: comparison with low-dose — View Citation
Lessick J, Dragu R, Mutlak D, Rispler S, Beyar R, Litmanovich D, Engel A, Agmon Y, Kapeliovich M, Hammerman H, Ghersin E. Is functional improvement after myocardial infarction predicted with myocardial enhancement patterns at multidetector CT? Radiology. — View Citation
Mahnken AH, Koos R, Katoh M, Wildberger JE, Spuentrup E, Buecker A, Günther RW, Kühl HP. Assessment of myocardial viability in reperfused acute myocardial infarction using 16-slice computed tomography in comparison to magnetic resonance imaging. J Am Coll — View Citation
Nieman K, Cury RC, Ferencik M, Nomura CH, Abbara S, Hoffmann U, Gold HK, Jang IK, Brady TJ. Differentiation of recent and chronic myocardial infarction by cardiac computed tomography. Am J Cardiol. 2006 Aug 1;98(3):303-8. Epub 2006 Jun 6. — View Citation
Nieman K, Shapiro MD, Ferencik M, Nomura CH, Abbara S, Hoffmann U, Gold HK, Jang IK, Brady TJ, Cury RC. Reperfused myocardial infarction: contrast-enhanced 64-Section CT in comparison to MR imaging. Radiology. 2008 Apr;247(1):49-56. doi: 10.1148/radiol.24 — View Citation
Nikolaou K, Sanz J, Poon M, Wintersperger BJ, Ohnesorge B, Rius T, Fayad ZA, Reiser MF, Becker CR. Assessment of myocardial perfusion and viability from routine contrast-enhanced 16-detector-row computed tomography of the heart: preliminary results. Eur R — View Citation
Rubinshtein R, Miller TD, Williamson EE, Kirsch J, Gibbons RJ, Primak AN, McCollough CH, Araoz PA. Detection of myocardial infarction by dual-source coronary computed tomography angiography using quantitated myocardial scintigraphy as the reference standa — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of stay | 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. | First 24 to 72 hours | |
Secondary | Direct patient costs | Direct patient costs will be measured in both study arms | First 24 to 72 hours |
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