Coronary Artery StenosisCARS-320NCT00967876
Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study
An observational study of Coronary Artery Stenosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents. 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
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Nov 2011
- 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: Patients who underwent coronary artery stent placement in the past and are clinically indicated to undergo conventional coronary angiography.
Who may be able to join
- Suspected coronary artery in-stent restenoses 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 40 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.
- Resting heart rate above 70 beats per minute and contraindications to beta blockers (e.g. moderate to severe bronchospastic disease, asthma)
- Atrial fibrillation, uncontrolled tachycardia, A-V block II or III degree or other non-sinus rhythms
- Inability to hold the breath for 10 seconds
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- Hypotension < 80 mmHg systolic
- Unstable angina pectoris, acute myocardial infarction < 48h
- Continuous therapy with Dipyridamol
- Severe aortic stenosis
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.
- Conditions
- Coronary Artery Stenosis
- Keywords
- Men or women of any ethnic group scheduled to undergo conventional coronary angiography for suspected coronary artery stent stenosis
- Medical subject headings
- Coronary Stenosis, Multiple Endocrine Neoplasia Type 1
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 startApr 2009
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Dewey, Charite University, Berlin, Germany
- Investigators
- Marc Dewey, MD, PhD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967876
- Sponsor's protocol ID
- EA1/133/08
- Acronym
- CARS-320
- Status last verified
- Jul 2014
- First submitted
- 27 Aug 2009
- Last updated
- 23 Jul 2014
- Results posted
- 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. Coronary CT versus MR angiography: pro CT--the role of CT angiography. Radiology. 2011 Feb;258(2):329-39. doi: 10.1148/radiol.10100161. No abstract available.
PubMed 21273517Rief M, Zimmermann E, Stenzel F, Martus P, Stangl K, Greupner J, Knebel F, Kranz A, Schlattmann P, Laule M, Dewey M. Computed tomography angiography and myocardial computed tomography perfusion in patients with coronary stents: prospective intraindividual comparison with conventional coronary angiography. J Am Coll Cardiol. 2013 Oct 15;62(16):1476-85. doi: 10.1016/j.jacc.2013.03.088. Epub 2013 Jun 19.
PubMed 23792193Preuss D, Garcia G, Laule M, Dewey M, Rief M. Myocardial CT perfusion imaging for the detection of obstructive coronary artery disease: multisegment reconstruction does not improve diagnostic performance. Eur Radiol Exp. 2022 Jan 31;6(1):5. doi: 10.1186/s41747-021-00256-8.
PubMed 35099638Rief M, Feger S, Martus P, Laule M, Dewey M, Schonenberger E. Acceptance of Combined Coronary CT Angiography and Myocardial CT Perfusion versus Conventional Coronary Angiography in Patients with Coronary Stents--Intraindividual Comparison. PLoS One. 2015 Sep 1;10(9):e0136737. doi: 10.1371/journal.pone.0136737. eCollection 2015.
PubMed 26327127Feger S, Rief M, Zimmermann E, Martus P, Schuijf JD, Blobel J, Richter F, Dewey M. The Impact of Different Levels of Adaptive Iterative Dose Reduction 3D on Image Quality of 320-Row Coronary CT Angiography: A Clinical Trial. PLoS One. 2015 May 6;10(5):e0125943. doi: 10.1371/journal.pone.0125943. eCollection 2015.
PubMed 25945924
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study
- ClinicalTrials.gov ID
- NCT00967876
- Acronym / sponsor ID
- CARS-320 / EA1/133/08
- Conditions
- Coronary Artery Stenosis
- Keywords
- Men or women of any ethnic group scheduled to undergo conventional coronary angiography for suspected coronary artery stent stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2011 (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 investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent coronary artery stent placement in the past and are clinically indicated to undergo conventional coronary angiography.
Key inclusion criteria (2 listed)
- Suspected coronary artery in-stent restenoses 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 (10 listed)
- Creatinine of above 2.0 mg/dl
- Age below 40 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.
- Resting heart rate above 70 beats per minute and contraindications to beta blockers (e.g. moderate to severe bronchospastic disease, asthma)
- Atrial fibrillation, uncontrolled tachycardia, A-V block II or III degree or other non-sinus rhythms
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 Jul 2014.
- 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 21273517Dewey M. Coronary CT versus MR angiography: pro CT--the role of CT angiography. Radiology. 2011 Feb;258(2):329-39. doi: 10.1148/radiol.10100161. No abstract available.
- Results publication: PubMed 23792193Rief M, Zimmermann E, Stenzel F, Martus P, Stangl K, Greupner J, Knebel F, Kranz A, Schlattmann P, Laule M, Dewey M. Computed tomography angiography and myocardial computed tomography perfusion in patients with coronary stents: prospective intraindividual comparison with conventional coronary angiography. J Am Coll Cardiol. 2013 Oct 15;62(16):1476-85. doi: 10.1016/j.jacc.2013.03.088. Epub 2013 Jun 19.
- Derived from this study: PubMed 35099638Preuss D, Garcia G, Laule M, Dewey M, Rief M. Myocardial CT perfusion imaging for the detection of obstructive coronary artery disease: multisegment reconstruction does not improve diagnostic performance. Eur Radiol Exp. 2022 Jan 31;6(1):5. doi: 10.1186/s41747-021-00256-8.
- Derived from this study: PubMed 26327127Rief M, Feger S, Martus P, Laule M, Dewey M, Schonenberger E. Acceptance of Combined Coronary CT Angiography and Myocardial CT Perfusion versus Conventional Coronary Angiography in Patients with Coronary Stents--Intraindividual Comparison. PLoS One. 2015 Sep 1;10(9):e0136737. doi: 10.1371/journal.pone.0136737. eCollection 2015.
- Derived from this study: PubMed 25945924Feger S, Rief M, Zimmermann E, Martus P, Schuijf JD, Blobel J, Richter F, Dewey M. The Impact of Different Levels of Adaptive Iterative Dose Reduction 3D on Image Quality of 320-Row Coronary CT Angiography: A Clinical Trial. PLoS One. 2015 May 6;10(5):e0125943. doi: 10.1371/journal.pone.0125943. eCollection 2015.
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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, 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 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 10 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 Jul 2014. 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 NCT00967876, which also lists 7 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 Jul 2014.