Coronary Artery DiseaseVICTORYNCT01856504
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY
An observational study of Coronary Artery Disease and Coronary Arteriosclerosis, run by MDDX LLC at 7 sites in 5 countries.
Trial summary
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Arteriosclerosis
- How many people
- 218 participants
- Where
- 7 sitesin 5 countries
- Study dates
- May 2013to Mar 2015
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consenting adult patients ≥18 years of age, Suspected but without known prior history of CAD, Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
Who may be able to join
- Consenting adult patients ≥18 years of age;
- Suspected but without known prior history of CAD
- Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
- Glomerular filtration rate >60 ml/min
- CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)
Who cannot join
- Incomplete ICA or CCTA;
- Known CAD (prior myocardial infarction, PCI, CABG)
- Atrial Fibrillation
- Abnormal Renal Function (GFR <60 ml/min)
- Unwilling or unable to give consent
- Non-cardiac illness with life expectancy <1 year
Show all 12Show fewer
- Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
- Pregnant women
- Allergy to iodinated contrast agent
- Contraindications to nitroglycerin
- Systolic blood pressure ≤90 mm Hg
- Contraindications to β blockers or nitroglycerin
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
United States3 sites
Walter Reed Medical Center
Bethesda, Maryland
Midwest Cardiology Associates
Independence, Missouri
MDDX
San Francisco, California, 94104
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
Read the detailed description
Hypothesis: Coronary CT angiography (CCTA) employing a novel intracycle motion compensation algorithm (SnapShot Freeze [SSF]) will be superior to CCTA without an intracycle motion compensation algorithm ("conventional" CCTA) for diagnostic accuracy and image quality.
Scientific Basis: Preliminary study (Leipsic, Min, Journal of Cardiovascular Computed Tomography [in press]) of coronary CT angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of CCTA using SSF compared to CCTA not using SSF. Importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. While not statistically powered on a per-patient basis, per-segment diagnostic accuracy of CCTA using SSF was superior to conventional CCTA. These results are complementary to those derived from internal testing at GE Healthcare wherein phantom work has demonstrated improved diagnostic performance using SSF compared to conventional image acquisitions.
Long-term Goal/Purpose: To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. If the aims of this study are achieved, the use of SSF for effective temporal resolution improvement may obviate (or reduce) the need for CT hardware for improved temporal resolution.
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis
- Keywords
- Heart Disease, Coronary Artery Disease, Coronary Arteriosclerosis
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CCTA Patient | 1. Consenting adult patients ≥18 years of age; 2. Suspected but without known prior history of CAD 3. Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin) 4. Glomerular filtration rate >60 ml/min 5. CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Measured: 30 days
Diagnostic Interpretability
To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Measured: 30 days
Image quality
To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Measured: 30 day
Secondary outcomes (2)
Upper threshold of heart rate
To determine the upper threshold of heart rate below which CCTA with SSF is most effective.
Measured: 1 day
incremental & additive value
To determine the incremental \& additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
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.
- 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
- 218 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- MDDX LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856504
- Sponsor's protocol ID
- VICTORY
- Acronym
- VICTORY
- Status last verified
- Mar 2015
- First submitted
- 15 May 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01856504
- Acronym / sponsor ID
- VICTORY / VICTORY
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis
- Keywords
- Heart Disease, Coronary Artery Disease, Coronary Arteriosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- MDDX LLCIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 May 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.
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
Detailed description
Hypothesis: Coronary CT angiography (CCTA) employing a novel intracycle motion compensation algorithm (SnapShot Freeze [SSF]) will be superior to CCTA without an intracycle motion compensation algorithm ("conventional" CCTA) for diagnostic accuracy and image quality.
Scientific Basis: Preliminary study (Leipsic, Min, Journal of Cardiovascular Computed Tomography [in press]) of coronary CT angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of CCTA using SSF compared to CCTA not using SSF. Importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. While not statistically powered on a per-patient basis, per-segment diagnostic accuracy of CCTA using SSF was superior to conventional CCTA. These results are complementary to those derived from internal testing at GE Healthcare wherein phantom work has demonstrated improved diagnostic performance using SSF compared to conventional image acquisitions.
Long-term Goal/Purpose: To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. If the aims of this study are achieved, the use of SSF for effective temporal resolution improvement may obviate (or reduce) the need for CT hardware for improved temporal resolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA Patient | – | –1. Consenting adult patients ≥18 years of age; 2. Suspected but without known prior history of CAD 3. Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin) 4. Glomerular filtration rate >60 ml/min 5. CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consenting adult patients ≥18 years of age, Suspected but without known prior history of CAD, Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
Key inclusion criteria (5 listed)
- Consenting adult patients ≥18 years of age;
- Suspected but without known prior history of CAD
- Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
- Glomerular filtration rate >60 ml/min
- CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)
Key exclusion criteria (12 listed)
- Incomplete ICA or CCTA;
- Known CAD (prior myocardial infarction, PCI, CABG)
- Atrial Fibrillation
- Abnormal Renal Function (GFR <60 ml/min)
- Unwilling or unable to give consent
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
Diagnostic Accuracy
Time frame: 30 days
To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Diagnostic Interpretability
Time frame: 30 days
To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Image quality
Time frame: 30 day
To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
2 secondary outcomes
Upper threshold of heart rate
Time frame: 1 day
incremental & additive value
Time frame: 1 day
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 3 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 and Coronary Arteriosclerosis, run by MDDX LLC at 7 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 12 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Argentina, Canada, India, Italy. 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?
Diagnostic Accuracy (time frame: 30 days). The study lists 3 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 3 Apr 2015.