Coronary Artery DiseaseC-Sub320NCT02011061
Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography
An observational study of Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 countries.
Trial summary
Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 182 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2013to Jun 2016
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (N=200) referred for in hospital invasive coronary evaluation
Who may be able to join
- Age > 55 Years
- Scheduled for invasive coronary angiography
- Logistically possible to perform CCTA before invasive evaluation
Who cannot join
- Known Iodine-contrast allergy
- Estimated GFR below 50 ml/min
- Atrial fibrillation or other persistence cardiac arrythmia
- Contraindication to betablockers (bronchospasm, LVEF less than 40%)
- Implanted PM or ICD
- Previous mechanical heart valve surgery
- Inability to maintain breath-hold for at least 5 sec
- Patient-related condition resulting the inability of the patient to understand the informed consent form of the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
National Heart, Lung and Blood Institute
Bethesda, Maryland, 20892
Denmark1 site
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, 2100
About this study
Official title: Prospective International Study of Coronary Substraction Using 320 Row-detector CT
Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction.
The primary hypothesis of the study is:
- Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to conventional CCTA on a per-patient basis
Read the detailed description
CCTA is a very important clinical method for the clinical evaluation of patients with chest pain of potential cardiac ischemic origin. However Coronary calcification and/or previously implanted coronary stents may limit the diagnostic accuracy of CCTA. A novel approach - coronary calcium subtraction - has been developed to potentially overcome this limitation.
- Study Objective: To assess diagnostic accuracy using coronary calcium subtraction coronary CT angiography (CCTA) as compared to conventional CCTA.
- Material and Methods: A total of 200 patients with suspected or known coronary artery disease (CAD) who have been referred for invasive coronary angiography (ICA) will prior to ICA undergo additional research CCTA with the newly developed coronary calcium subtraction protocol. Based on the coronary calcium scan (CS), coronary calcium score will be calculated according to the Agatston score. Conventional contrast enhanced CCTA studies will be analyzed for image quality and the presence and extent of coronary stenosis. Using a dedicated algorithm, subtraction will be performed on all datasets to obtain CCTA subtraction images. Subtracted images will be analyzed similar to the conventional CCTA images. ICA will serve as the gold standard. Image quality will be compared between conventional and subtracted CCTA. In addition, diagnostic accuracy in the evaluation of coronary stenosis as determined on ICA will be compared. Finally, factors influencing the performance of coronary calcium subtraction will be evaluated.
- Conditions
- Coronary Artery Disease
- Keywords
- Multidetector Computed Tomography, Coronary Stenosis, Coronary Artery Disease, Angina Pectoris
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Coronary Subtraction Coronary CT angiography
Sensitivity, Specificity, Negative and Positive predictive value of Coronary Subtraction CT angiography by visual assessment to identify a >50% coronary stenosis as defined by invasive coronary angiography on a patient by patient level.
Measured: Within 90 days of ICA and CCTA
Secondary outcomes (3)
Coronary CT angiography reader confidence
Coronary CT angiography reader confidence by a 3 level visual scale assessed on CT images without and with Coronary Calcium Subtraction
Measured: Within 90 days of ICA and CCTA
Coronary stenosis severity in non-diagnostic or partially diagnostic segments by conventional CCTA
In coronary segments deemed non-diagnostic or partially diagnostic due to calcification or coronary stents by conventional CCTA concordance of stenosis severity by Coronary Subtraction CT angiography and invasive quantitative coronary angiography is assessed
Measured: Within 90 days of ICA and CCTA
Coronary revascularization
On a patient by patient level the ability of CCTA to predict need for coronary revascularization (PCI or CABG) is assessed using CCTA without and with coronary calcium subtraction
Measured: Within 30 days after CCTA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Klaus Fuglsang Kofoed, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Klaus F Kofoed, MD, DmSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011061
- Sponsor's protocol ID
- H-3-2013-108
- Other IDs
- ZIAHL006138
- Acronym
- C-Sub320
- Status last verified
- Jan 2021
- First submitted
- 2 Dec 2013
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdulla J, Pedersen KS, Budoff M, Kofoed KF. Influence of coronary calcification on the diagnostic accuracy of 64-slice computed tomography coronary angiography: a systematic review and meta-analysis. Int J Cardiovasc Imaging. 2012 Apr;28(4):943-53. doi: 10.1007/s10554-011-9902-6. Epub 2011 Jun 12.
PubMed 21667273Tanaka R, Yoshioka K, Muranaka K, Chiba T, Ueda T, Sasaki T, Fusazaki T, Ehara S. Improved evaluation of calcified segments on coronary CT angiography: a feasibility study of coronary calcium subtraction. Int J Cardiovasc Imaging. 2013 Dec;29 Suppl 2:75-81. doi: 10.1007/s10554-013-0316-5. Epub 2013 Oct 25.
PubMed 24158235Fuchs A, Kuhl JT, Chen MY, Helqvist S, Razeto M, Arakita K, Steveson C, Arai AE, Kofoed KF. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography. J Cardiovasc Comput Tomogr. 2015 Sep-Oct;9(5):393-8. doi: 10.1016/j.jcct.2015.03.016. Epub 2015 Apr 16.
PubMed 26091841
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective International Study of Coronary Substraction Using 320 Row-detector CT
- ClinicalTrials.gov ID
- NCT02011061
- Acronym / sponsor ID
- C-Sub320 / H-3-2013-108
- Conditions
- Coronary Artery Disease
- Keywords
- Multidetector Computed Tomography, Coronary Stenosis, Coronary Artery Disease, Angina Pectoris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Dec 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.
Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction.
The primary hypothesis of the study is:
- Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to conventional CCTA on a per-patient basis
Detailed description
CCTA is a very important clinical method for the clinical evaluation of patients with chest pain of potential cardiac ischemic origin. However Coronary calcification and/or previously implanted coronary stents may limit the diagnostic accuracy of CCTA. A novel approach - coronary calcium subtraction - has been developed to potentially overcome this limitation.
- Study Objective: To assess diagnostic accuracy using coronary calcium subtraction coronary CT angiography (CCTA) as compared to conventional CCTA.
- Material and Methods: A total of 200 patients with suspected or known coronary artery disease (CAD) who have been referred for invasive coronary angiography (ICA) will prior to ICA undergo additional research CCTA with the newly developed coronary calcium subtraction protocol. Based on the coronary calcium scan (CS), coronary calcium score will be calculated according to the Agatston score. Conventional contrast enhanced CCTA studies will be analyzed for image quality and the presence and extent of coronary stenosis. Using a dedicated algorithm, subtraction will be performed on all datasets to obtain CCTA subtraction images. Subtracted images will be analyzed similar to the conventional CCTA images. ICA will serve as the gold standard. Image quality will be compared between conventional and subtracted CCTA. In addition, diagnostic accuracy in the evaluation of coronary stenosis as determined on ICA will be compared. Finally, factors influencing the performance of coronary calcium subtraction will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (N=200) referred for in hospital invasive coronary evaluation
Key inclusion criteria (3 listed)
- Age > 55 Years
- Scheduled for invasive coronary angiography
- Logistically possible to perform CCTA before invasive evaluation
Key exclusion criteria (8 listed)
- Known Iodine-contrast allergy
- Estimated GFR below 50 ml/min
- Atrial fibrillation or other persistence cardiac arrythmia
- Contraindication to betablockers (bronchospasm, LVEF less than 40%)
- Implanted PM or ICD
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 of Coronary Subtraction Coronary CT angiography
Time frame: Within 90 days of ICA and CCTA
Sensitivity, Specificity, Negative and Positive predictive value of Coronary Subtraction CT angiography by visual assessment to identify a >50% coronary stenosis as defined by invasive coronary angiography on a patient by patient level.
3 secondary outcomes
Coronary CT angiography reader confidence
Time frame: Within 90 days of ICA and CCTA
Coronary stenosis severity in non-diagnostic or partially diagnostic segments by conventional CCTA
Time frame: Within 90 days of ICA and CCTA
Coronary revascularization
Time frame: Within 30 days after CCTA
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 7 Jan 2021.
- Background: PubMed 21667273Abdulla J, Pedersen KS, Budoff M, Kofoed KF. Influence of coronary calcification on the diagnostic accuracy of 64-slice computed tomography coronary angiography: a systematic review and meta-analysis. Int J Cardiovasc Imaging. 2012 Apr;28(4):943-53. doi: 10.1007/s10554-011-9902-6. Epub 2011 Jun 12.
- Background: PubMed 24158235Tanaka R, Yoshioka K, Muranaka K, Chiba T, Ueda T, Sasaki T, Fusazaki T, Ehara S. Improved evaluation of calcified segments on coronary CT angiography: a feasibility study of coronary calcium subtraction. Int J Cardiovasc Imaging. 2013 Dec;29 Suppl 2:75-81. doi: 10.1007/s10554-013-0316-5. Epub 2013 Oct 25.
- Background: PubMed 26091841Fuchs A, Kuhl JT, Chen MY, Helqvist S, Razeto M, Arakita K, Steveson C, Arai AE, Kofoed KF. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography. J Cardiovasc Comput Tomogr. 2015 Sep-Oct;9(5):393-8. doi: 10.1016/j.jcct.2015.03.016. Epub 2015 Apr 16.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Klaus F Kofoed, MD, DmSc principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 2 countries: 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 Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 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 3 inclusion and 8 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 7 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 2 sites in United States, Denmark. 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 of Coronary Subtraction Coronary CT angiography (time frame: Within 90 days of ICA and CCTA). 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 NCT02011061, which also lists 3 linked publications.
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 7 Jan 2021.