NCT00738218

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
Last Updated

August 20, 2008

Status Verified

August 1, 2008

Enrollment Period

1.3 years

First QC Date

August 19, 2008

Last Update Submit

August 19, 2008

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseComputed TomographyAngiography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.

    30 Days

Secondary Outcomes (1)

  • Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.

    30 Days

Study Arms (1)

MDCT

OTHER

Single Arm study. All patients underwent MDCT.

Other: Multidetector Computed Tomography - 64 detectors

Interventions

Multidetector Computed Tomography - 64 detectorsOTHER

Multidetector computed tomography angiography

Also known as: Aquillion 64 detector CT scanner
MDCT

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25281436DERIVED

  • 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.

    PMID: 23932641DERIVED

  • 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.

    PMID: 20170786DERIVED

  • 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.

    PMID: 19038879DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

October 1, 2005

Primary Completion

February 1, 2007

Last Updated

August 20, 2008

Record last verified: 2008-08