Coronary Artery DiseaseMEDICNCT01190579
Dual Source CT Angiography for Detection of Coronary Artery Stenoses
An observational study of Coronary Artery Disease, run by University of Erlangen-Nürnberg Medical School at 8 sites in 5 countries.
Trial summary
The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 398 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Aug 2009to Dec 2010
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chest Pain and an Intermdiate Likelihood for Coronary Artery Stenoses
Who may be able to join
- suspected coronary artery disease
- chest Pain
- intermediate likelihood of coronary stenoses
- planned invasive coronary angiography
- age 30 to 80 years
Who cannot join
- non sinus rhythm
- contrast allergy
- renal failure
- unstable clinical condition
- previous coronary revascularization
- calcium score exceeding 800
Show all 10Show fewer
- inability to perform 10 second breathhold
- possible pregnancy
- metformin medication that cannot be interrupted
- inability to establish antecubital iv access
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Germany4 sites, 4 recruiting
- Recruiting
University of Erlangen
Erlangen
Stephan Achenbach, MD, ++49 9131 8535000, stephan.achenbach@uk-erlangen.de
Stephan Achenbach, MD
- Recruiting
Roentgenpraxis Hamburg
Hamburg
Joern Sandstede
- Recruiting
Deutsches Herzzentrum Muenchen
München
Joerg Hausleiter, MD, joerg.hausleiter@dhm.mhn.de
Joerg Hausleiter, MD
- Not yet recruiting
Klinikum Grosshadern
Munich
Christoph Becker, MD
Denmark1 site, 1 recruiting
- Recruiting
Vejle Medical Center
Vejle
Kristian Ovrehus, MD
Mexico1 site, 1 recruiting
- Recruiting
Cardiovascular Institute
Monterrey
Erasmo De La Pena, MD
Singapore1 site, 1 recruiting
- Recruiting
Tan Tok Seng Hospital
Singapore
Keng Thye Ho, MD
About this study
Official title: Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses
The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Chest Pain, Computed Tomography
- Medical subject headings
- Coronary Artery Disease, Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy for the detection of coronary artery stenoses
Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.
Measured: 72 hours
Secondary outcomes (1)
Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography
Patients will be monitored for one hour after injection of Ultravist 370 and Ultravist 300 intravenously to assess safety and detect side effects.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions, Bayer
- Investigators
- Stephan Achenbach, MD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190579
- Sponsor's protocol ID
- MEDIC
- Acronym
- MEDIC
- Status last verified
- Aug 2010
- First submitted
- 20 Aug 2010
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses
- ClinicalTrials.gov ID
- NCT01190579
- Acronym / sponsor ID
- MEDIC / MEDIC
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Chest Pain, Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions, Bayer
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 Aug 2010 (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 trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chest Pain and an Intermdiate Likelihood for Coronary Artery Stenoses
Key inclusion criteria (5 listed)
- suspected coronary artery disease
- chest Pain
- intermediate likelihood of coronary stenoses
- planned invasive coronary angiography
- age 30 to 80 years
Key exclusion criteria (10 listed)
- non sinus rhythm
- contrast allergy
- renal failure
- unstable clinical condition
- previous coronary revascularization
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
Accuracy for the detection of coronary artery stenoses
Time frame: 72 hours
Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.
1 secondary outcome
Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
Stephan Achenbach, MD principal investigator
University of Erlangen-Nürnberg
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Erlangen-Nürnberg Medical School at 8 sites in 5 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Denmark, India, Mexico, Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan Achenbach, MD (++49 9131 8535000, stephan.achenbach@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy for the detection of coronary artery stenoses (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2010.