Coronary Artery StenosisNCT00721851
320-slice Coronary Computed Tomography (CT) Angiography
An observational study of Coronary Artery Stenosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Dec 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive eligible patients referred to the Charité and scheduled to undergo conventional coronary angiography.
Who may be able to join
- 40 years of age
- sinus rhythm
Who cannot join
- prior conventional coronary angiography
- unstable presentation
- coronary artery bypass graft or stent
- pregnancy or breast-feeding
- creatinine > 2.0 mg per deciliter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Artery Imaging With 320-slice Computed Tomography
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.
- Conditions
- Coronary Artery Stenosis
- Medical subject headings
- Coronary Stenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Marc Dewey, MD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721851
- Sponsor's protocol ID
- EA1/140/07
- Status last verified
- Feb 2009
- First submitted
- 23 Jul 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18263576Zimmermann 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, 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.
PubMed 20234975Dewey 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 19704093
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Imaging With 320-slice Computed Tomography
- ClinicalTrials.gov ID
- NCT00721851
- Acronym / sponsor ID
- EA1/140/07
- Conditions
- Coronary Artery Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Jul 2008 (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 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive eligible patients referred to the Charité and scheduled to undergo conventional coronary angiography.
Key inclusion criteria (2 listed)
- 40 years of age
- sinus rhythm
Key exclusion criteria (5 listed)
- prior conventional coronary angiography
- unstable presentation
- coronary artery bypass graft or stent
- pregnancy or breast-feeding
- creatinine > 2.0 mg per deciliter
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 23 Jun 2011.
- Background: PubMed 18263576Dewey 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.
- 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 20234975Dewey 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.
- Results publication: 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.
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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 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 Coronary Artery Stenosis, 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 5 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 23 Jun 2011. 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 NCT00721851, which also lists 4 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 23 Jun 2011.