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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00968279
Other study ID # EA1/134/08
Secondary ID
Status Completed
Phase N/A
First received August 27, 2009
Last updated May 2, 2013
Start date August 2009
Est. completion date September 2012

Study information

Verified date April 2013
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Department for Radiation Protection
Study type Observational

Clinical Trial Summary

The primary objective of this study is to analyze the diagnostic accuracy of coronary CT angiography using 320 simultaneous detector results in patients with atrial fibrillation.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Suspected coronary artery disease based on clinical findings or findings on other noninvasive imaging tests and planned coronary angiography within the next 14 days.

- Able to understand and willing to sign the Informed CF.

Exclusion Criteria:

- Creatinine of above 2.0 mg/dl

- Age below 50 years

- Women of child bearing potential (no hysterectomy, no menopause, or menopause since less than 12 months) must demonstrate a negative pregnancy test performed within 24 hours before CT.

- Inability to hold the breath for 10 seconds

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Charité Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Dewey M, Oncel D, Oncel G, Tastan A. Coronary CT angiography in patients with atrial fibrillation. Radiology. 2008 Aug;248(2):701; author reply 701-2. doi: 10.1148/radiol.2482080062. — View Citation

Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dübel 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. — View Citation

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. — View Citation

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