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Diagnostic Accuracy of Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors

NCT ID: NCT00738218

Last Updated: 2008-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease Computed Tomography Angiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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MDCT

Single Arm study. All patients underwent MDCT.

Group Type OTHER

Multidetector Computed Tomography - 64 detectors

Intervention Type OTHER

Multidetector computed tomography angiography

Interventions

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Multidetector Computed Tomography - 64 detectors

Multidetector computed tomography angiography

Intervention Type OTHER

Other Intervention Names

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Aquillion 64 detector CT scanner

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toshiba America Medical Systems, Inc.

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Johns Hopkins University

Principal Investigators

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Joao AC Lima, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Julie M Miller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Joao AC Lima, M.D.

Role: STUDY_CHAIR

Johns Hopkins University

References

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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.

Reference Type DERIVED
PMID: 25281436 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23932641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20170786 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19038879 (View on PubMed)

Other Identifiers

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NA_00003755

Identifier Type: -

Identifier Source: secondary_id

NTR535

Identifier Type: -

Identifier Source: secondary_id

JHUCORE64

Identifier Type: -

Identifier Source: org_study_id