Acute Chest Pain Imaging in the ED With the Combine CCTA and CT Perfusion

NCT02538861 | Completed

• 1 other identifier: IRB#15-062
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Direct patient costs

  First 24 to 72 hours

Study Arms (3)

ARM-A

Arm-A patients will receive the standard of care diagnostic test at Baptist Hospital, which includes SPECT imaging

Diagnostic Test: SPECT Imaging Test at Baptist hospital

ARM-B (Group-1)

Group-1 will receive CT Angiography and CT myocardial perfusion with new Revolution CT scanner.

Diagnostic Test: CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital

ARM-B (Group-2)

The Group-2 of arm B will receive SPECT imaging test.

Diagnostic Test: SPECT Imaging Test at West Kendall Baptist Hospital

Interventions

SPECT Imaging Test at Baptist hospital DIAGNOSTIC_TEST

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

ARM-A

CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital DIAGNOSTIC_TEST

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

ARM-B (Group-1)

SPECT Imaging Test at West Kendall Baptist Hospital DIAGNOSTIC_TEST

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

ARM-B (Group-2)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria: * \> 35 years of age * Patient had an episode of chest pain at rest or during exercise within the past 24 hours * Patient is classified as Level 3 Baptist Chest Pain Protocol or the patient is classified as "Level 4" and has either a 40-70% stenosis by coronary CT angiography, an Agatston Calcium Score \>400, or non-evaluable segments in coronary CT angiography * Women of childbearing potential have a negative pregnancy test * Patient understands the study requirements and procedures and provides written informed consent before any study specific test or procedures * Patient is willing to comply with the specified follow-up telephone call Exclusion Criteria: * Patient is classified as Level 1, Level 2, or Level 5 in the Miami Baptist Chest Pain Protocol * Known allergy to iodinated contrast agent or creatinine \>1.5mmol/L * Atrial Fibrillation, Flutter or irregular heart rhythm * Known history of severe asthma * Body Mass Index \>45 * Patients in unstable conditions

You may qualify if:

• The patient is \> 35 years of age.
• The patient had an episode of chest pain at rest or during exercise within the previous 24 hours.
• 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.
• Women of childbearing potential have a negative pregnancy urine or serum test.
• 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.
• The patient is willing to comply with the specified follow-up telephone call.

You may not qualify if:

• 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)
• Known allergy to iodinated contrast agent or creatinine \>1.5mmol/L.
• Atrial Fibrillation, Flutter or irregular heart rhythm.
• Known history of severe asthma.
• Body Mass Index (BMI) \>45.
• Patients in unstable conditions.

Sponsors & Collaborators

• Baptist Health South Florida: lead
• GE Healthcare: collaborator

Study Sites (2)

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

West Kendall Baptist Hospital

Miami, Florida, 33196, United States

Location

Related Publications (10)

• 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 64-section multidetector CT. Radiology. 2008 Aug;248(2):466-75. doi: 10.1148/radiol.2482071478.

  PMID: 18641250 RESULT

• 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 dobutamine echocardiography. J Am Coll Cardiol. 2007 Mar 20;49(11):1178-85. doi: 10.1016/j.jacc.2006.12.032. Epub 2007 Mar 6.

  PMID: 17367662 RESULT

• 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. 2007 Sep;244(3):736-44. doi: 10.1148/radiol.2443061397. Epub 2007 Aug 9.

  PMID: 17690323 RESULT

• Mahnken AH, Koos R, Katoh M, Wildberger JE, Spuentrup E, Buecker A, Gunther RW, Kuhl HP. Assessment of myocardial viability in reperfused acute myocardial infarction using 16-slice computed tomography in comparison to magnetic resonance imaging. J Am Coll Cardiol. 2005 Jun 21;45(12):2042-7. doi: 10.1016/j.jacc.2005.03.035.

  PMID: 15963407 RESULT

• 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. doi: 10.1016/j.amjcard.2006.01.101. Epub 2006 Jun 6.

  PMID: 16860013 RESULT

• 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.2471070332.

  PMID: 18372464 RESULT

• 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 Radiol. 2005 May;15(5):864-71. doi: 10.1007/s00330-005-2672-6. Epub 2005 Mar 18.

  PMID: 15776243 RESULT

• 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 standard. Heart. 2009 Sep;95(17):1419-22. doi: 10.1136/hrt.2008.158618. Epub 2009 Feb 5.

  PMID: 19196731 RESULT

• 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. doi: 10.1161/01.cir.101.23.2734.

  PMID: 10851212 RESULT

• Cury RC, Feuchtner GM, Batlle JC, Pena 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. 2013 Jan;200(1):57-65. doi: 10.2214/AJR.12.8808.

  PMID: 23255742 RESULT

MeSH Terms

Conditions

Chest Pain

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Ricardo C Cury, MD

  Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)