Coronary Artery DiseaseCTAS-MCASNCT01779986
Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram
An observational study of Coronary Artery Disease, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and convention coronary angiogram results in patients who are scheduled for an ascending aorta aneurysm reparation surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Feb 2015
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ascending aorta aneurysm undergoing preoperative evaluation of CAD by CT-Angioscan and Coronary angiogramm before surgical reparation.
Who may be able to join
- Ascending aorta aneurysm waiting for surgical correction
- Willing to participate
- Needing a Coronary angiogram and a CT-AS for medical reasons
Who cannot join
- Refuse to participate
- Allergy to contrast material
- Incomplete results or having one of the test done in another hospital
- Arrythmia
- More than 6 months between the two exams
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4
Paul Farand, M.Sc, 819-346-1110, paul.farand@sherbrooke.ca
Gérald Gahide, MD
About this study
Official title: Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram in Patient as Part of Preoperative Evaluation in Ascending Aorta Replacement Surgery Patients.
The use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and convention coronary angiogram results in patients who are scheduled for an ascending aorta aneurysm reparation surgery. These examens are standard of care before this surgery, so there is no additional danger or disadvantage for the patient. We hope to confirm that CT-AS is a reliable screening test for CAD in patient undergoing heart surgery for other reason than CAD.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of CAD
The CAD seen on CT-AS as compared to the results of the gold-standard test of coronary angiogram.
Measured: less than 6 monthes between two tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (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 Université de SherbrookeThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Gahide, MD PHD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779986
- Sponsor's protocol ID
- CTAS-MCAS UdeS 12-073
- Acronym
- CTAS-MCAS
- Status last verified
- Jan 2013
- First submitted
- 28 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram in Patient as Part of Preoperative Evaluation in Ascending Aorta Replacement Surgery Patients.
- ClinicalTrials.gov ID
- NCT01779986
- Acronym / sponsor ID
- CTAS-MCAS / CTAS-MCAS UdeS 12-073
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 30 Jan 2013 (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 use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and convention coronary angiogram results in patients who are scheduled for an ascending aorta aneurysm reparation surgery. These examens are standard of care before this surgery, so there is no additional danger or disadvantage for the patient. We hope to confirm that CT-AS is a reliable screening test for CAD in patient undergoing heart surgery for other reason than CAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ascending aorta aneurysm undergoing preoperative evaluation of CAD by CT-Angioscan and Coronary angiogramm before surgical reparation.
Key inclusion criteria (3 listed)
- Ascending aorta aneurysm waiting for surgical correction
- Willing to participate
- Needing a Coronary angiogram and a CT-AS for medical reasons
Key exclusion criteria (5 listed)
- Refuse to participate
- Allergy to contrast material
- Incomplete results or having one of the test done in another hospital
- Arrythmia
- More than 6 months between the two exams
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
Presence of CAD
Time frame: less than 6 monthes between two tests
The CAD seen on CT-AS as compared to the results of the gold-standard test of coronary angiogram.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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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.
Gerald Gahide, MD PHD principal investigator
Université de Sherbrooke
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 Disease, run by Université de Sherbrooke at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Jan 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of CAD (time frame: less than 6 monthes between two tests). 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 30 Jan 2013.