NCT00721851

Brief Summary

The primary aim of this study is to determine the potential utility of 320-slice volume-CT for obtaining adequate diagnostic accuracy while at the same time improving image quality compared with previous generations of CT scanners and simultaneously enabling a reduction in both radiation exposure and contrast agent amount required.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 23, 2011

Status Verified

February 1, 2009

Enrollment Period

8 months

First QC Date

July 23, 2008

Last Update Submit

June 21, 2011

Conditions

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive eligible patients referred to the Charité and scheduled to undergo conventional coronary angiography.

You may qualify if:

  • years of age
  • sinus rhythm

You may not qualify if:

  • prior conventional coronary angiography
  • unstable presentation
  • coronary artery bypass graft or stent
  • pregnancy or breast-feeding
  • creatinine \> 2.0 mg per deciliter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (4)

  • Dewey M, Zimmermann E, Laule M, Rutsch W, Hamm B. Three-vessel coronary artery disease examined with 320-slice computed tomography coronary angiography. Eur Heart J. 2008 Jul;29(13):1669. doi: 10.1093/eurheartj/ehm626. Epub 2008 Feb 7. No abstract available.

    PMID: 18263576BACKGROUND
  • Zimmermann E, Dewey M. Whole-heart 320-row computed tomography: reduction of radiation dose via prior coronary calcium scanning. Rofo. 2011 Jan;183(1):54-9. doi: 10.1055/s-0029-1245629. Epub 2010 Aug 19.

    PMID: 20725881BACKGROUND
  • Dewey M, de Vries H, de Vries L, Haas D, Leidecker C. The present and future of cardiac CT in research and clinical practice: moderated discussion and scientific debate with representatives from the four main vendors. Rofo. 2010 Apr;182(4):313-21. doi: 10.1055/s-0029-1245195. Epub 2010 Mar 16.

    PMID: 20234975BACKGROUND
  • Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24.

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Marc Dewey, MD

    Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 23, 2011

Record last verified: 2009-02

Locations