Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography - Full Text View

Purpose

The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥ 50% and a corresponding myocardium perfusion defect in a patient with suspected coronary artery disease compared with conventional coronary angiography and single photon emission computed tomography myocardium perfusion imaging.

Condition	Intervention	Phase
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease	Procedure: 320 Volume Detector Computed Tomography Other: Other: Multidetector Computed Tomography - 320 detectors	Phase 3

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Multi Center Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Computed Tomography

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Coronary Artery Disease Heart Diseases Vascular Diseases

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in a patient with suspected coronary artery disease. [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diagnostic accuracy of volume computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding territorial myocardium perfusion defects in a vessel of a patient with suspected CAD. [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]
The combination of biomarkers and CT imaging obtained at baseline is superior to imaging or biomarkers alone in the i.d. of patients who will undergo subsequent coronary revascularization, and/or develop a major coronary event within 2 years. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]
Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography. [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]

Enrollment:	444
Study Start Date:	December 2009
Estimated Study Completion Date:	September 2016
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Combined CT Angiography and Myocardial Perfusion Single Arm study. All patients underwent combined CT Angiography and Myocardial Perfusion.	Procedure: 320 Volume Detector Computed Tomography Single Arm Study. All patients undergo Volume (Multidetector) CT. Other: Other: Multidetector Computed Tomography - 320 detectors Multidetector computed tomography angiography Other Name: Aquilion ONE CT scanner

Detailed Description:

The Combined Coronary angiography and myocardial perfusion imaging using 320 detectors computed tomography (CORE-320) was designed as a prospective, multi-center, international, blinded study designed to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in patients with suspected coronary artery disease. The primary analysis will be a comparison of the diagnostic capability of the combination of quantitative 320-MDCT angiography and quantitative perfusion imaging to the combination of conventional coronary angiography and SPECT myocardial perfusion imaging at the patient level. A positive patient will be defined as having at least one vessel with a ≥ 50% diameter stenosis defined by quantitative coronary angiography and a corresponding positive SPECT territorial myocardial perfusion defect.

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients, age 45-85. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
Suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography; and planned coronary angiography within the next 60 days.
Able to understand and willing to sign the Informed Consent Form.

Exclusion Criteria:

Known allergy to iodinated contrast media.
History of contrast-induced nephropathy.
History of multiple myeloma or previous organ transplantation.
Elevated serum creatinine (> 1.5 mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula.
Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block).
Evidence of severe symptomatic heart failure (NYHA Class III or IV); Known or suspected moderate or severe aortic stenosis.
Previous coronary artery bypass or other cardiac surgery.
Coronary artery intervention within the last 6 months.
Known or suspected intolerance or contraindication to beta-blockers including:
- Known allergy to beta-blockers
- History of moderate to severe bronchospastic lung disease (including moderate to severe asthma).
Severe pulmonary disease (chronic obstructive pulmonary disease).
Presence of any other history or condition that the investigator feels would be problematic.
SPECT preformed in non-validated center within 60 days prior to screening.
SPECT performed within the previous 6 months of screening but > 60 days.
SPECT studies performed within 60 days of screening that include rest and stress studies performed using 2 day protocols.
BMI greater than 40

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934037

Locations

United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
National Heart Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women Hospital
Boston, Massachusetts, United States, 02215
Brazil
INCOR Heart Institute University-Sao Paulo
Sao Paulo, Brazil
Albert Einstein Hospital
Sao Paulo, Brazil
Canada
Toronto General Hospital
Toronto, Canada
Denmark
Rigshospitalet - University of Copenhagen
Blegdamsvej, Denmark, 9, 2100
Germany
Charite Humboldt University
Berlin, Germany
Japan
Iwate Medical University
Morioka, Japan
St. Luke's International Hospital
Tokyo, Japan
Keio University
Tokyo, Japan
Mie University
TSU, Japan
Netherlands
Leiden University
Leiden, Netherlands
Singapore
National Heart Center
Singapore, Singapore
Mount Elizabeth Hospital
Singapore, Singapore

Sponsors and Collaborators

Johns Hopkins University

Toshiba America Medical Systems, Inc.

Investigators

Study Chair:

Joao AC Lima, MD MBA

Johns Hopkins School of Medicine

More Information

Publications:

Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36.

Vavere AL, Simon GG, George RT, Rochitte CE, Arai AE, Miller JM, Di Carli M, Zadeh AA, Dewey M, Niinuma H, Laham R, Rybicki FJ, Schuijf JD, Paul N, Hoe J, Kuribyashi S, Sakuma H, Nomura C, Yaw TS, Kofoed KF, Yoshioka K, Clouse ME, Brinker J, Cox C, Lima JA. Diagnostic performance of combined noninvasive coronary angiography and myocardial perfusion imaging using 320 row detector computed tomography: design and implementation of the CORE320 multicenter, multinational diagnostic study. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):370-81. Epub 2011 Nov 12.

Miller JM, Dewey M, Vavere AL, Rochitte CE, Niinuma H, Arbab-Zadeh A, Paul N, Hoe J, de Roos A, Yoshioka K, Lemos PA, Bush DE, Lardo AC, Texter J, Brinker J, Cox C, Clouse ME, Lima JA. Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64. Eur Radiol. 2009 Apr;19(4):816-28. doi: 10.1007/s00330-008-1203-7. Epub 2008 Nov 8.

Yoneyama K, Vavere AL, Cerci R, Ahmed R, Arai AE, Niinuma H, Rybicki FJ, Rochitte CE, Clouse ME, George RT, Lima JA, Arbab-Zadeh A. Influence of image acquisition settings on radiation dose and image quality in coronary angiography by 320-detector volume computed tomography: the CORE320 pilot experience. Heart Int. 2012 Jun 5;7(2):e11. doi: 10.4081/hi.2012.e11. Epub 2012 Jun 25.

Cerci RJ, Arbab-Zadeh A, George RT, Miller JM, Vavere AL, Mehra V, Yoneyama K, Texter J, Foster C, Guo W, Cox C, Brinker J, Di Carli M, Lima JA. Aligning coronary anatomy and myocardial perfusion territories: an algorithm for the CORE320 multicenter study. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):587-95. Epub 2012 Aug 10.

George RT, Arbab-Zadeh A, Miller JM, Vavere AL, Bengel FM, Lardo AC, Lima JA. Computed tomography myocardial perfusion imaging with 320-row detector computed tomography accurately detects myocardial ischemia in patients with obstructive coronary artery disease. Circ Cardiovasc Imaging. 2012 May 1;5(3):333-40. doi: 10.1161/CIRCIMAGING.111.969303. Epub 2012 Mar 23.

George RT, Arbab-Zadeh A, Cerci RJ, Vavere AL, Kitagawa K, Dewey M, Rochitte CE, Arai AE, Paul N, Rybicki FJ, Lardo AC, Clouse ME, Lima JA. Diagnostic performance of combined noninvasive coronary angiography and myocardial perfusion imaging using 320-MDCT: the CT angiography and perfusion methods of the CORE320 multicenter multinational diagnostic study. AJR Am J Roentgenol. 2011 Oct;197(4):829-37. doi: 10.2214/AJR.10.5689.

Mehra VC, Valdiviezo C, Arbab-Zadeh A, Ko BS, Seneviratne SK, Cerci R, Lima JA, George RT. A stepwise approach to the visual interpretation of CT-based myocardial perfusion. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):357-69. doi: 10.1016/j.jcct.2011.10.010. Epub 2011 Oct 31. Review.

Responsible Party:	Joao A.C Lima, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00934037 History of Changes
Other Study ID Numbers:	Core320
Study First Received:	May 11, 2009
Last Updated:	December 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Coronary Artery Disease
Computed Tomography
Myoperfusion
Angiography
SPECT

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease

Heart Diseases
Ischemia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography (Core320)