Coronary Artery DiseaseNCT01189331
CT Coronary Angiography and Computational Fluid Dynamics
A study testing CT coronary angiography and computational fluid dynamics in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. 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?
- CT coronary angiography and computational fluid dynamics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2009to 31 Dec 2020
- 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
- Significant stenosis at CT angiography
- Normal ejection fraction on echocardiography
- Informed consented patient
Who cannot join
- total occlusion and collateral flow to target vessel
- AV conduction abnormality
- Left ventricular hypertrophy
- significant valvular heart or primary myocardial disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics
Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.
- Conditions
- Coronary Artery Disease
- Being tested
- CT coronary angiography and computational fluid dynamics
- Keywords
- Coronary artery disease, CT, Computational flow dynamics
- 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.
CT coronary angiography and computational fluid dynamicsDevice
Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics
| Study group | Role | What they receive |
|---|---|---|
| CT and FFR | No intervention | Not described Receives: Device: CT coronary angiography and computational fluid dynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional flow reserve
fractional flow reserve of stenotic coronary artery
Measured: 1day
target vessel failure
composite of cardiovascular death, target vessel myocardial infarction, target vessel revascularization
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study start13 Oct 2009
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Seoul National University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University, Pauls Stradins Clinical University Hospital, Cornell University, Ulsan university, Indiana University, Stanford University
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189331
- Sponsor's protocol ID
- H-1007-193-325
- Status last verified
- Mar 2021
- First submitted
- 15 Aug 2010
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang S, Chung J, Lesina K, Doh JH, Jegere S, Erglis A, Leipsic JA, Fearon WF, Narula J, Koo BK. Long-term prognostic implications of CT angiography-derived fractional flow reserve: Results from the DISCOVER-FLOW study. J Cardiovasc Comput Tomogr. 2024 May-Jun;18(3):251-258. doi: 10.1016/j.jcct.2024.01.016. Epub 2024 Feb 19.
PubMed 38378313Yang S, Lesina K, Doh JH, Jegere S, Erglis A, Leipsic JA, Chun EJ, Choi G, Schaap M, Zarins C, Taylor CA, Fearon WF, Narula J, Koo BK. Long-term prognostic implications of hemodynamic and plaque assessment using coronary CT angiography. Atherosclerosis. 2023 May;373:58-65. doi: 10.1016/j.atherosclerosis.2023.02.005. Epub 2023 Feb 27.
PubMed 36872186Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
PubMed 22032711
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics
- ClinicalTrials.gov ID
- NCT01189331
- Acronym / sponsor ID
- H-1007-193-325
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, CT, Computational flow dynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Inje University, Pauls Stradins Clinical University Hospital, Cornell University, Ulsan university, Indiana University, Stanford University
- Study start
- 13 Oct 2009 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Aug 2010 (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.
Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT and FFR | No intervention | Device: CT coronary angiography and computational fluid dynamics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Significant stenosis at CT angiography
- Normal ejection fraction on echocardiography
- Informed consented patient
Key exclusion criteria (4 listed)
- total occlusion and collateral flow to target vessel
- AV conduction abnormality
- Left ventricular hypertrophy
- significant valvular heart or primary myocardial disease
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 |
|---|---|---|
| CT coronary angiography and computational fluid dynamicsEvaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics | Device | CT and FFR |
Primary outcome
fractional flow reserve
Time frame: 1day
fractional flow reserve of stenotic coronary artery
target vessel failure
Time frame: 10 year
composite of cardiovascular death, target vessel myocardial infarction, target vessel revascularization
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 16 Mar 2021.
- Derived from this study: PubMed 38378313Yang S, Chung J, Lesina K, Doh JH, Jegere S, Erglis A, Leipsic JA, Fearon WF, Narula J, Koo BK. Long-term prognostic implications of CT angiography-derived fractional flow reserve: Results from the DISCOVER-FLOW study. J Cardiovasc Comput Tomogr. 2024 May-Jun;18(3):251-258. doi: 10.1016/j.jcct.2024.01.016. Epub 2024 Feb 19.
- Derived from this study: PubMed 36872186Yang S, Lesina K, Doh JH, Jegere S, Erglis A, Leipsic JA, Chun EJ, Choi G, Schaap M, Zarins C, Taylor CA, Fearon WF, Narula J, Koo BK. Long-term prognostic implications of hemodynamic and plaque assessment using coronary CT angiography. Atherosclerosis. 2023 May;373:58-65. doi: 10.1016/j.atherosclerosis.2023.02.005. Epub 2023 Feb 27.
- Derived from this study: PubMed 22032711Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
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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.
Bon-Kwon Koo, MD, PhD principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT coronary angiography and computational fluid dynamics in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 16 Mar 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 South Korea. 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?
fractional flow reserve (time frame: 1day). The study lists 2 primary outcomes in all. 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 NCT01189331, 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 16 Mar 2021.