NCT00968279

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Typical duration 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

August 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

3.1 years

First QC Date

August 27, 2009

Last Update Submit

May 2, 2013

Conditions

Keywords

Patients with atrial fibrillation

Study Arms (1)

Atrial Fibrillation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with atrial fibrillation scheduled to undergo coronary angiography due to suspected coronary artery disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (3)

  • 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, 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.

    PMID: 19704093BACKGROUND
  • 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. No abstract available.

    PMID: 18641260BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Dewey, MD, PhD

    Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations