Coronary ArteriosclerosisPhase 4NCT00371891
Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)
A Phase 4 study testing Multidetector Computed Tomography Coronary Angiography in people with Coronary Arteriosclerosis and Cardiomyopathies, run by St. Joseph's Healthcare Hamilton at 4 sites in Canada.
Trial summary
Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently demonstrated to be accurate and may be used as a potential alternative to conventional invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis, Cardiomyopathies, Heart Defects, Congenital
- What is being tested?
- Multidetector Computed Tomography Coronary Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 2006to Jun 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1
- Valvular heart disease (mitral stenosis, mitral regurgitation, aortic stenosis or aortic insufficiency) or
- Congenital heart disease (i.e. VSD, ASD, PDA) or
- Cardiomyopathy OR
- Group 2
- Intermediate probability of coronary artery disease (probability of 10-90%) after clinical evaluation and traditional non-invasive testing
Who cannot join
- Age < 18 years
- Lack of consent
- Renal Insufficiency (GFR < 60 mL/min)
- Allergy to contrast agent
- Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
- Pregnancy or breast feeding
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- Uncontrolled heart rate
- Previous CABG or PCI/Stent
- Chronic atrial fibrillation
- History of acute myocardial infarction, as defined by a creatine kinase (CK) level greater than 2 times normal with a troponin level above 4.
- Unable to perform 20 second breath-hold
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)
Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently demonstrated to be accurate and may be used as a potential alternative to conventional invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of coronary artery disease. The purpose of this study is to see if MDCTCA can identify significant coronary artery disease as good as or better than conventional coronary angiography (CICA). The study is designed to enroll 900 subjects and is being conducted in 6 hospitals in Ontario. Subjects scheduled for conventional cardiac catheterization and coronary angiography will receive an additional test using MDCTCA. The information gathered during the MDCTCA will be compared to the results of the scheduled conventional invasive coronary angiogram.
- Conditions
- Coronary Arteriosclerosis, Cardiomyopathies, Heart Defects, Congenital, Heart Valve Diseases
- Being tested
- Multidetector Computed Tomography Coronary Angiography
- Medical subject headings
- Coronary Artery Disease, Cardiomyopathies, Heart Defects, Congenital, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidetector Computed Tomography Coronary AngiographyProcedure or surgery
1 Multidetector Computed Tomography Coronary Angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of MDCTCA as compared to CICA
Measured: After both MDCTCA and CICA are completed
Secondary outcomes (3)
Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.
Measured: After both MDCTCA and CICA are completed
The accuracy of MDCTCA to CICA will be compared in categorizing patients inot single, double, triple vessel, left main disease or no coronary stenosis.
Measured: After both MDCTCA and CICA are completed
The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.
Measured: After both MDCTCA and CICA are completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Investigators
- Michael Freeman, MD, Study chair, Unity Health TorontoAlan Moody, MD, Principal investigator, Sunnybrook Health Sciences CentreBenjamin Chow, MD, Principal investigator, Ottawa Heart Institute Research CorporationRonald Goeree, MA, Study chair, Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster UniversityNarinder Paul, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371891
- Sponsor's protocol ID
- HTA007-0603-01
- Status last verified
- Nov 2010
- First submitted
- 1 Sep 2006
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chow BJ, Freeman MR, Bowen JM, Levin L, Hopkins RB, Provost Y, Tarride JE, Dennie C, Cohen EA, Marcuzzi D, Iwanochko R, Moody AR, Paul N, Parker JD, O'Reilly DJ, Xie F, Goeree R. Ontario multidetector computed tomographic coronary angiography study: field evaluation of diagnostic accuracy. Arch Intern Med. 2011 Jun 13;171(11):1021-9. doi: 10.1001/archinternmed.2011.74. Epub 2011 Mar 14.
PubMed 21403014
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)
- ClinicalTrials.gov ID
- NCT00371891
- Acronym / sponsor ID
- HTA007-0603-01
- Conditions
- Coronary Arteriosclerosis, Cardiomyopathies, Heart Defects, Congenital, Heart Valve Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Sep 2006 (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.
Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently demonstrated to be accurate and may be used as a potential alternative to conventional invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of coronary artery disease. The purpose of this study is to see if MDCTCA can identify significant coronary artery disease as good as or better than conventional coronary angiography (CICA). The study is designed to enroll 900 subjects and is being conducted in 6 hospitals in Ontario. Subjects scheduled for conventional cardiac catheterization and coronary angiography will receive an additional test using MDCTCA. The information gathered during the MDCTCA will be compared to the results of the scheduled conventional invasive coronary angiogram.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Group 1
- Valvular heart disease (mitral stenosis, mitral regurgitation, aortic stenosis or aortic insufficiency) or
- Congenital heart disease (i.e. VSD, ASD, PDA) or
- Cardiomyopathy OR
- Group 2
Key exclusion criteria (11 listed)
- Age < 18 years
- Lack of consent
- Renal Insufficiency (GFR < 60 mL/min)
- Allergy to contrast agent
- Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidetector Computed Tomography Coronary Angiography1 Multidetector Computed Tomography Coronary Angiography | Procedure or surgery | – |
Primary outcome
Sensitivity and specificity of MDCTCA as compared to CICA
Time frame: After both MDCTCA and CICA are completed
3 secondary outcomes
Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.
Time frame: After both MDCTCA and CICA are completed
The accuracy of MDCTCA to CICA will be compared in categorizing patients inot single, double, triple vessel, left main disease or no coronary stenosis.
Time frame: After both MDCTCA and CICA are completed
The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.
Time frame: After both MDCTCA and CICA are completed
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 25 Nov 2010.
- Derived from this study: PubMed 21403014Chow BJ, Freeman MR, Bowen JM, Levin L, Hopkins RB, Provost Y, Tarride JE, Dennie C, Cohen EA, Marcuzzi D, Iwanochko R, Moody AR, Paul N, Parker JD, O'Reilly DJ, Xie F, Goeree R. Ontario multidetector computed tomographic coronary angiography study: field evaluation of diagnostic accuracy. Arch Intern Med. 2011 Jun 13;171(11):1021-9. doi: 10.1001/archinternmed.2011.74. Epub 2011 Mar 14.
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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.
Michael Freeman, MD study chair
Unity Health Toronto
Alan Moody, MD principal investigator
Sunnybrook Health Sciences Centre
Benjamin Chow, MD principal investigator
Ottawa Heart Institute Research Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multidetector Computed Tomography Coronary Angiography in people with Coronary Arteriosclerosis and Cardiomyopathies, run by St. Joseph's Healthcare Hamilton at 4 sites 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 6 inclusion and 11 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Sensitivity and specificity of MDCTCA as compared to CICA (time frame: After both MDCTCA and CICA are completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371891, which also lists 1 linked publication.
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 25 Nov 2010.