Coronary Artery DiseaseNCT04712513
Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dynamic cardiac CT perfusion imaging
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2021to Mar 2024
- How long will I take part?
- 6 Months
- 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: Eligible patients are those who have clinically indicated referral for cardiac catheterization based on clinical history and sign of ischemia or obstructive coronary lesion(s) from non-invasive imaging test (radionuclide myocardial perfusion imaging, CMR myocardial perfusion imaging, or CCTA).
- Subject Inclusion Criteria Patients need to meet all the following inclusion criteria to be enrolled in the study:
- Symptomatic and hemodynamically stable
- Acute coronary syndrome (ACS) ruled out based on absence of abnormal changes in ECG and cardiac enzymes
- Referral for cardiac catheterization based on clinical history and non-invasive imaging test findings. Non-invasive imaging findings include one or more of the following: (i) Evidence of myocardial ischemia from radionuclide myocardial perfusion imaging; (ii) Evidence of myocardial ischemia from CMR myocardial perfusion imaging; (iii) Evidence of ≥ 50% stenosis in the left circumflex artery (LCx), left anterior descending artery (LAD) and/or right coronary artery (RCA) from CCTA.
- Ability to undergo stress myocardial perfusion test (absence of contraindications for vasodilator)
- Written informed consent
- Subject Exclusion Criteria
Patients meeting at least one of the following criteria will be excluded from the study:
- Recent (< 1 month) ACS
- CCTA reveals ≥ 50% stenosis in the left main artery
- Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- Contraindications to stress perfusion imaging, including: i) severe reactive airway disease; ii) high-grade atrioventricular block; iii) allergy to vasodilators; iv) caffeine within 12 hours; v) theophylline use within 48 hours.
- History of CABG surgery
- History of malignancy during the past 3 years prior to screening
- History of alcohol and/or drug abuse within 3 years prior to screening
- Sign of pregnancy
- Pregnant or nursing
- History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents
- Recent (< 1 month) use of an investigational drug or device
- Participation in any other investigational drug or device trial during the conduct of this study
- Lack of ability or willingness to comply with the protocol requirements or deemed by the Site Investigator to be unfit for the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
St Joseph's Hospital
London, Ontario, N6A 4V2
Aaron So, PhD, (519)9315777 ext. 24224, aso@robarts.ca
Aaron So, PhD
About this study
Official title: Multicenter Diagnostic Performance of Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease
The objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). The proposed CTP technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (FFR) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with CAD. The CTP results will be compared with invasive coronary angiography / FFR assessment and non-invasive cardiac magnetic resonance imaging (CMR) / radionuclide perfusion assessment.
- Conditions
- Coronary Artery Disease
- Being tested
- Dynamic cardiac CT perfusion imaging
- Keywords
- Computed Tomography, Myocardial Perfusion, Fractional Flow Reserve
- 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.
Dynamic cardiac CT perfusion imagingDiagnostic test
Multiple images of the heart are acquired with a clinical CT scanner after an intravenous bolus injection of contrast solution. The images are then analyzed to provide fractional flow reserve and myocardial perfusion values.
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary artery disease and hemodynamically stable | Not described Receives: Diagnostic Test: Dynamic cardiac CT perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis
Comparison with invasive coronary angiography and FFR assessment
Measured: Within 4 weeks prior to invasive cardiac catheterization
Accuracy of FFR obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis
Comparison with invasive coronary angiography and FFR assessment
Measured: Within 4 weeks prior to invasive cardiac catheterization
Accuracy of combined myocardial perfusion and FFR measurement obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis
Comparison with invasive coronary angiography and FFR assessment
Measured: Within 4 weeks prior to invasive cardiac catheterization
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and static CT perfusion
Comparison in patients with multi-vessel CAD where balanced ischemia is expected
Measured: Within 4 weeks prior to invasive cardiac catheterization
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and CT-FFR (based on computational fluid dynamics simulation)
Comparison in patients with dense coronary calcification
Measured: Within 4 weeks prior to invasive cardiac catheterization
Secondary outcomes (2)
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques
Comparison with CMR / radionuclide perfusion assessment
Measured: Within 4 weeks of the acquisition of non-CT perfusion imaging
Comparison of diagnostic accuracy of dynamic CT perfusion for functional CAD assessment between male and female patients
Sex-based analysis
Measured: Within 4 weeks prior to invasive cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2024 (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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), London Health Sciences Centre
- Responsible party
- Principal investigator, Aaron So, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712513
- Sponsor's protocol ID
- 12052020
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Diagnostic Performance of Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04712513
- Acronym / sponsor ID
- 12052020
- Conditions
- Coronary Artery Disease
- Keywords
- Computed Tomography, Myocardial Perfusion, Fractional Flow Reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), London Health Sciences Centre
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 15 Jan 2021 (actual)
- 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 objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). The proposed CTP technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (FFR) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with CAD. The CTP results will be compared with invasive coronary angiography / FFR assessment and non-invasive cardiac magnetic resonance imaging (CMR) / radionuclide perfusion assessment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary artery disease and hemodynamically stable | – | Diagnostic Test: Dynamic cardiac CT perfusion imaging |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are those who have clinically indicated referral for cardiac catheterization based on clinical history and sign of ischemia or obstructive coronary lesion(s) from non-invasive imaging test (radionuclide myocardial perfusion imaging, CMR myocardial perfusion imaging, or CCTA).
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 |
|---|---|---|
| Dynamic cardiac CT perfusion imagingMultiple images of the heart are acquired with a clinical CT scanner after an intravenous bolus injection of contrast solution. The images are then analyzed to provide fractional flow reserve and myocardial perfusion values. | Diagnostic test | Patients with coronary artery disease and hemodynamically stable |
Primary outcome
Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis
Time frame: Within 4 weeks prior to invasive cardiac catheterization
Comparison with invasive coronary angiography and FFR assessment
Accuracy of FFR obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis
Time frame: Within 4 weeks prior to invasive cardiac catheterization
Comparison with invasive coronary angiography and FFR assessment
Accuracy of combined myocardial perfusion and FFR measurement obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis
Time frame: Within 4 weeks prior to invasive cardiac catheterization
Comparison with invasive coronary angiography and FFR assessment
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and static CT perfusion
Time frame: Within 4 weeks prior to invasive cardiac catheterization
Comparison in patients with multi-vessel CAD where balanced ischemia is expected
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and CT-FFR (based on computational fluid dynamics simulation)
Time frame: Within 4 weeks prior to invasive cardiac catheterization
Comparison in patients with dense coronary calcification
2 secondary outcomes
Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques
Time frame: Within 4 weeks of the acquisition of non-CT perfusion imaging
Comparison of diagnostic accuracy of dynamic CT perfusion for functional CAD assessment between male and female patients
Time frame: Within 4 weeks prior to invasive cardiac catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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?
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 15 Jan 2021. 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?
Contact Aaron So, PhD ((519)9315777 ext. 24224, aso@robarts.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis (time frame: Within 4 weeks prior to invasive cardiac catheterization). The study lists 5 primary outcomes in all. 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 15 Jan 2021.