Atrial FibrillationNCT00968279
Coronary CT Angiography Using 320-Row Volume CT in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation scheduled to undergo coronary angiography due to suspected coronary artery disease.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atrial Fibrillation
- Keywords
- Patients with atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Marc Dewey, MD, PhD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968279
- Sponsor's protocol ID
- EA1/134/08
- Status last verified
- Apr 2013
- First submitted
- 27 Aug 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20725881Dewey 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.
PubMed 19704093Dewey 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.
PubMed 18641260
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography Using 320-Row Volume CT in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00968279
- Acronym / sponsor ID
- EA1/134/08
- Conditions
- Atrial Fibrillation
- Keywords
- Patients with atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation scheduled to undergo coronary angiography due to suspected coronary artery disease.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Background: PubMed 20725881Zimmermann 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.
- Background: PubMed 19704093Dewey 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.
- Background: PubMed 18641260Dewey 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.
Related trials for Atrial Fibrillation
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Dewey, MD, PhD principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968279, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.