Clinical trial NCT00738218: Diagnostic Accuracy of Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors
Official title: Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors: "CORE-64" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Computed Tomography
Angiography
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Toshiba America Medical Systems, Inc.
First posted: 2008-08-20
Enrollment: 405
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.
timeFrame: 30 Days
Secondary outcomes:
measure: Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.
timeFrame: 30 Days
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Joao AC Lima, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Julie M Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Joao AC Lima, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.
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.