Diagnostic Accuracy of Multi-Detector Spiral Computed Tom... | NCT00738218

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

NCT00738218

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Aug 20, 2008Estimated

Enrollment

405Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Multidetector Computed Tomography - 64 detectors

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Feb 2007Actual

Completion Date

Not provided

First Submitted Date

Aug 19, 2008

First Submission Date that Met QC Criteria

Aug 19, 2008

First Posted Date

Aug 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2008

Last Update Posted Date

Aug 20, 2008Estimated

Name	Class
Toshiba America Medical Systems, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

405Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDCT	Other	Single Arm study. All patients underwent MDCT.	Other: Multidetector Computed Tomography - 64 detectors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multidetector Computed Tomography - 64 detectors	Other	Multidetector computed tomography angiography	MDCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.		30 Days

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.		30 Days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joao AC Lima, M.D.	Johns Hopkins University	Principal Investigator
Julie M Miller, M.D.	Johns Hopkins University	Principal Investigator
Joao AC Lima, M.D.	Johns Hopkins University	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25281436	Derived	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.
23932641

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Type	Description	Link
NA_00003755
NTR535