Coronary Artery DiseaseNCT01478100
Virtual Coronary Intervention and Non-invasive Fractional Flow Reserve (FFR)
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators examined the feasibility of treatment planning using virtual coronary revascularization and fractional flow reserve (FFR) CT before the invasive procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Nov 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: From the DISCOVER-FLOW study 20 patients with available post-intervention FFR were included in this study.
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
The investigators examined the feasibility of treatment planning using virtual coronary revascularization and fractional flow reserve (FFR) CT before the invasive procedures.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, CT, Computational flow dynamics
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478100
- Sponsor's protocol ID
- H-1109-106-379
- Status last verified
- Nov 2011
- First submitted
- 20 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KH, Doh JH, Koo BK, Min JK, Erglis A, Yang HM, Park KW, Lee HY, Kang HJ, Kim YJ, Lee SY, Kim HS. A novel noninvasive technology for treatment planning using virtual coronary stenting and computed tomography-derived computed fractional flow reserve. JACC Cardiovasc Interv. 2014 Jan;7(1):72-8. doi: 10.1016/j.jcin.2013.05.024. Epub 2013 Dec 11.
PubMed 24332418
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Coronary Intervention and Non-invasive Fractional Flow Reserve (FFR)
- ClinicalTrials.gov ID
- NCT01478100
- Acronym / sponsor ID
- H-1109-106-379
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, CT, Computational flow dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Nov 2011 (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.
The investigators examined the feasibility of treatment planning using virtual coronary revascularization and fractional flow reserve (FFR) CT before the invasive procedures.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From the DISCOVER-FLOW study 20 patients with available post-intervention FFR were included in this study.
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.
Primary outcome
Not reported in the source record.
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 23 Nov 2011.
- Derived from this study: PubMed 24332418Kim KH, Doh JH, Koo BK, Min JK, Erglis A, Yang HM, Park KW, Lee HY, Kang HJ, Kim YJ, Lee SY, Kim HS. A novel noninvasive technology for treatment planning using virtual coronary stenting and computed tomography-derived computed fractional flow reserve. JACC Cardiovasc Interv. 2014 Jan;7(1):72-8. doi: 10.1016/j.jcin.2013.05.024. Epub 2013 Dec 11.
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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.
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 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 23 Nov 2011. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478100, which also lists 1 linked publication.
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 23 Nov 2011.