Coronary Artery DiseaseNCT00449943
Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)
A study testing Computed Tomographic Angiography and Myocardial Perfusion Imaging Scan in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Cardiovascular disease and ischemic heart disease is the #1 killer in Canada. Currently, Cardiac invasive catheterization angiography (CICA) is the gold standard for the assessment of the arteries in the heart. However, cardiac catheterization has risks which prohibit its use in all patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Computed Tomographic Angiography and Myocardial Perfusion Imaging Scan
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Dec 2010
- Phase
- Interventional
- 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
- Patients referred for Tc-99m SPECT or CTA; or
- Patients referred for CICA without preceding (< 12 months) MPI or CTA
Who cannot join
- Previous revascularization (PCI or CABG)
- Age < 18 years or lack of consent
- Renal Insufficiency (GFR < 60 ml/min)
- Allergy or contraindication to contrast agent or dipyridamole
- Refractory angina requiring urgent/emergent coronary angiography
- Contraindication to radiation exposure (e.g. pregnancy)
Show all 9Show fewer
- Uncontrolled HR
- Atrial fibrillation, frequent atrial or ventricular ectopy (> 1/minute)
- Unable to perform 10 second breath-hold
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular disease and ischemic heart disease is the #1 killer in Canada. Currently, Cardiac invasive catheterization angiography (CICA) is the gold standard for the assessment of the arteries in the heart. However, cardiac catheterization has risks which prohibit its use in all patients. These risks include: death, heart attack, stroke and bleeding. Cardiac computed tomography angiography (CTA) is a new non-invasive technology which may enable the evaluation of patients' coronary anatomy without exposing patients to the risks of invasive cardiac catheterization.
The purpose of this project is to compare CT angiography (CTA) to Tc-99m single photon emission computed tomography (Tc-99m SPECT)
We will enroll patients who are waiting for a CICA or who have been referred for a TC-99m SPECT or CTA scans at the University of Ottawa Heart Institute. Consenting patients who are waiting for a CICA will have both a CTA and a Tc-99m SPECT scan. Consenting patients referred for a CTA or Tc-99m SPECT will have both the CTA and Tc-99m SPECT in a random order but not CICA (unless ordered by your physician).
- Conditions
- Coronary Artery Disease
- Being tested
- Computed Tomographic Angiography, Myocardial Perfusion Imaging Scan
- Keywords
- Cardiac Invasive Catheterization Angiography, Single Photon Emission Computed Tomography, Computed Tomography Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomographic AngiographyProcedure or surgery
CT scan
Myocardial Perfusion Imaging ScanProcedure or surgery
SPECT
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the accuracy of CTA to SPECT for the diagnosis of CAD
Measured: 1 year
Secondary outcomes (1)
To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2010
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 Ottawa Heart Institute Research CorporationThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Chow, Ottawa Heart Institute Research Corporation
- Investigators
- Benjamin JW Chow, MD, FRCPC, Principal investigator, Ottawa Heart Institute Research CorporationRobert Beanlands, MD, Study chair, Ottawa Heart Institute Research CorporationTerrence Ruddy, MD, Study chair, Univeristy of Ottawa Heart InstituteCarole Dennie, MD, Study chair, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449943
- Sponsor's protocol ID
- 2006360-01H
- Status last verified
- Jan 2012
- First submitted
- 20 Mar 2007
- Last updated
- 26 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiac Computed Tomographic Angiography (CTA) to Tc-99m Single Photon Emission Computed Tomography (SPECT)
- ClinicalTrials.gov ID
- NCT00449943
- Acronym / sponsor ID
- 2006360-01H
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac Invasive Catheterization Angiography, Single Photon Emission Computed Tomography, Computed Tomography Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Mar 2007 (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.
Cardiovascular disease and ischemic heart disease is the #1 killer in Canada. Currently, Cardiac invasive catheterization angiography (CICA) is the gold standard for the assessment of the arteries in the heart. However, cardiac catheterization has risks which prohibit its use in all patients. These risks include: death, heart attack, stroke and bleeding. Cardiac computed tomography angiography (CTA) is a new non-invasive technology which may enable the evaluation of patients' coronary anatomy without exposing patients to the risks of invasive cardiac catheterization.
The purpose of this project is to compare CT angiography (CTA) to Tc-99m single photon emission computed tomography (Tc-99m SPECT)
We will enroll patients who are waiting for a CICA or who have been referred for a TC-99m SPECT or CTA scans at the University of Ottawa Heart Institute. Consenting patients who are waiting for a CICA will have both a CTA and a Tc-99m SPECT scan. Consenting patients referred for a CTA or Tc-99m SPECT will have both the CTA and Tc-99m SPECT in a random order but not CICA (unless ordered by your physician).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for Tc-99m SPECT or CTA; or
- Patients referred for CICA without preceding (< 12 months) MPI or CTA
Key exclusion criteria (9 listed)
- Previous revascularization (PCI or CABG)
- Age < 18 years or lack of consent
- Renal Insufficiency (GFR < 60 ml/min)
- Allergy or contraindication to contrast agent or dipyridamole
- Refractory angina requiring urgent/emergent coronary angiography
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 |
|---|---|---|
| Computed Tomographic AngiographyCT scan | Procedure or surgery | – |
| Myocardial Perfusion Imaging ScanSPECT | Procedure or surgery | – |
Primary outcome
To measure the accuracy of CTA to SPECT for the diagnosis of CAD
Time frame: 1 year
1 secondary outcome
To examine the accuracy of CTA predicting the mode of treatment: Medical therapy or revascularization (PCI versus CABG)
Time frame: 1 year
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 26 Jan 2012.
- University of Ottawa Heart InstituteLink provided by the sponsor.
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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.
Benjamin JW Chow, MD, FRCPC principal investigator
Ottawa Heart Institute Research Corporation
Robert Beanlands, MD study chair
Ottawa Heart Institute Research Corporation
Terrence Ruddy, MD study chair
Univeristy of Ottawa Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomographic Angiography and Myocardial Perfusion Imaging Scan in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation 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 2 inclusion and 9 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 26 Jan 2012. 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?
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?
To measure the accuracy of CTA to SPECT for the diagnosis of CAD (time frame: 1 year). 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 26 Jan 2012; AzTrials last refreshed its copy on 7 Nov 2026.