Diagnostic Accuracy of Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors (CORE-64)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multidetector Computed Tomography - 64 detectors
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Computed Tomography, Angiography
Eligibility Criteria
Inclusion Criteria:
- Male or female patients, age 40 years or greater.
- Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
- Suspected coronary artery disease (i.e. symptoms, signs) with a clinical indication for coronary angiography; and planned coronary angiography within the next 30 days.
- Able to understand and willing to sign informed consent.
Exclusion Criteria:
- Known allergy to iodinated contrast media
- History of contrast-induced nephropathy
- History of multiple myeloma or previous organ transplantation
- Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula
- Atrial fibrillation or uncontrolled tachyarrhythmia, or heart block
- Evidence of severe symptomatic heart failure; moderate or severe aortic stenosis
- Previous coronary artery bypass or other cardiac surgery
- Coronary artery intervention within the last 6 months
- Intolerance or contraindication to beta-blockers
- Body Mass Index > 40.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MDCT
Arm Description
Single Arm study. All patients underwent MDCT.
Outcomes
Primary Outcome Measures
Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.
Secondary Outcome Measures
Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.
Full Information
NCT ID
NCT00738218
First Posted
August 19, 2008
Last Updated
August 19, 2008
Sponsor
Johns Hopkins University
Collaborators
Toshiba America Medical Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00738218
Brief Title
Diagnostic Accuracy of Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors
Acronym
CORE-64
Official Title
Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors: "CORE-64" Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
Toshiba America Medical Systems, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the diagnostic ability of 64-detector MDCT coronary angiography with conventional invasive coronary angiography in patients with suspected coronary artery disease.
Detailed Description
The "Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors" or "CorE-64" study was designed to evaluate the diagnostic accuracy of multislice spiral CT angiography using 64 detector rows for identifying coronary artery stenosis in patients with suspected or known coronary artery disease. The study was designed as a prospective, multi-center, international, blinded study examining the diagnostic accuracy of 64-slice CT in comparison with CCA. The primary hypothesis of the study is that 64-slice CT coronary angiography will be able to detect significant coronary artery disease in a patient with acceptable diagnostic accuracy as compared to CCA. Significant CAD is defined as ≥ 50% stenosis as determined by quantitative analysis of CCA (QCA). The diagnostic parameters is per-patient sensitivity and specificity compared with CCA, with both point estimates and continuous measurements of diagnostic accuracy. Eligible patients will first undergo MDCT (calcium scanning and MDCTA)prior to clinically indicated conventional coronary angiography. Patients with CAC 600 or less will be included in the primary analysis. Patients will be followed for clinical events including revascularization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Computed Tomography, Angiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDCT
Arm Type
Other
Arm Description
Single Arm study. All patients underwent MDCT.
Intervention Type
Other
Intervention Name(s)
Multidetector Computed Tomography - 64 detectors
Other Intervention Name(s)
Aquillion 64 detector CT scanner
Intervention Description
Multidetector computed tomography angiography
Primary Outcome Measure Information:
Title
Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients, age 40 years or greater.
Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
Suspected coronary artery disease (i.e. symptoms, signs) with a clinical indication for coronary angiography; and planned coronary angiography within the next 30 days.
Able to understand and willing to sign informed consent.
Exclusion Criteria:
Known allergy to iodinated contrast media
History of contrast-induced nephropathy
History of multiple myeloma or previous organ transplantation
Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula
Atrial fibrillation or uncontrolled tachyarrhythmia, or heart block
Evidence of severe symptomatic heart failure; moderate or severe aortic stenosis
Previous coronary artery bypass or other cardiac surgery
Coronary artery intervention within the last 6 months
Intolerance or contraindication to beta-blockers
Body Mass Index > 40.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao AC Lima, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie M Miller, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joao AC Lima, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
25281436
Citation
Sara L, Rochitte CE, Lemos PA, Niinuma H, Dewey M, Shapiro EP, Gottlieb I, Mansur AP, Nicolau JC, Lardo AC, Azevedo CF, Kalil-Filho R, Vavere AL, Cohn S, Cox C, Brinker J, Miller JM, Lima JA. Accuracy of multidetector computed tomography for detection of coronary artery stenosis in acute coronary syndrome compared with stable coronary disease: a CORE64 multicenter trial substudy. Int J Cardiol. 2014 Dec 15;177(2):385-91. doi: 10.1016/j.ijcard.2014.08.130. Epub 2014 Aug 27.
Results Reference
derived
PubMed Identifier
23932641
Citation
Yan RT, Miller JM, Rochitte CE, Dewey M, Niinuma H, Clouse ME, Vavere AL, Brinker J, Lima JA, Arbab-Zadeh A. Predictors of inaccurate coronary arterial stenosis assessment by CT angiography. JACC Cardiovasc Imaging. 2013 Sep;6(9):963-72. doi: 10.1016/j.jcmg.2013.02.011. Epub 2013 Aug 8.
Results Reference
derived
PubMed Identifier
20170786
Citation
Gottlieb I, Miller JM, Arbab-Zadeh A, Dewey M, Clouse ME, Sara L, Niinuma H, Bush DE, Paul N, Vavere AL, Texter J, Brinker J, Lima JA, Rochitte CE. The absence of coronary calcification does not exclude obstructive coronary artery disease or the need for revascularization in patients referred for conventional coronary angiography. J Am Coll Cardiol. 2010 Feb 16;55(7):627-34. doi: 10.1016/j.jacc.2009.07.072.
Results Reference
derived
PubMed Identifier
19038879
Citation
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. doi: 10.1056/NEJMoa0806576.
Results Reference
derived
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Diagnostic Accuracy of Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors
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