Coronary Artery DiseaseNCT01413334
Transluminal Attenuation Gradient Versus CT Fractional Flow Reserve
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test, accurately evaluate anatomic coronary artery stenosis. However, anatomically-obstructive coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific ischemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected or known coronary artery disease (CAD) who underwent coronary CT angiography, invasive coronary angiography, and fractional flow reserve measurement between May, 2010 and January, 2011
Who may be able to join
- Age >= 18 years old
- CCTA with >=50% stenosis in a major coronary artery (>=2.0 mm diameter)
- underwent invasive coronary angiography with FFR measurement
Who cannot join
- with CCTA of poor image quality
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Bon-Kwon Koo, MD, PhD, 82-2-2072-2062, bkkoo@snu.ac.kr
Yeonyee E Yoon, MD, 82-2-2072-2677, islandtea@gmail.com
About this study
Official title: Noninvasive Diagnosis of Ischemia Causing Coronary Stenosis Using Coronary CT Angiograms (CCTA) : Comparison of Transluminal Attenuation Gradient (TAG) and Fractional Flow Reserve Computed From CCTA (FFR CT)
Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test, accurately evaluate anatomic coronary artery stenosis. However, anatomically-obstructive coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific ischemia. Recently, with the advance of imaging reconstruction and analysis technique, several novel parameters computed from CCTA were suggested to have added value in determining the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the presence of hemodynamically-significant coronary stenosis, as determined by fractional flow reserve (FFR).
Read the detailed description
Angiographically obtained fractional flow reserve (FFR) is a useful physiologic test for assessment of lesion-specific ischemia, and a valuable adjunct to anatomic assessment of coronary artery disease (CAD) as determined by invasive coronary angiography. However, the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test, accurately evaluate anatomic coronary artery stenosis. Although CCTA evaluation of CAD has been validated against invasive coronary angiography and intravascular ultrasound, anatomically-obstructive coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific ischemia. Recently, with the advance of imaging reconstruction and analysis technique, several novel parameters computed from CCTA were suggested to have added value in determining the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the presence of hemodynamically-significant coronary stenosis, as determined by FFR, will be compared to suggest best functional parameter noninvasively computed form CCTA.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, CT
- Medical subject headings
- Coronary Artery Disease
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (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 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413334
- Sponsor's protocol ID
- H-1106-076-366
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Diagnosis of Ischemia Causing Coronary Stenosis Using Coronary CT Angiograms (CCTA) : Comparison of Transluminal Attenuation Gradient (TAG) and Fractional Flow Reserve Computed From CCTA (FFR CT)
- ClinicalTrials.gov ID
- NCT01413334
- Acronym / sponsor ID
- H-1106-076-366
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center
- Study start
- May 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 10 Aug 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.
Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test, accurately evaluate anatomic coronary artery stenosis. However, anatomically-obstructive coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific ischemia. Recently, with the advance of imaging reconstruction and analysis technique, several novel parameters computed from CCTA were suggested to have added value in determining the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the presence of hemodynamically-significant coronary stenosis, as determined by fractional flow reserve (FFR).
Detailed description
Angiographically obtained fractional flow reserve (FFR) is a useful physiologic test for assessment of lesion-specific ischemia, and a valuable adjunct to anatomic assessment of coronary artery disease (CAD) as determined by invasive coronary angiography. However, the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. Coronary computed tomographic angiography (CCTA) has emerged as a non-invasive test, accurately evaluate anatomic coronary artery stenosis. Although CCTA evaluation of CAD has been validated against invasive coronary angiography and intravascular ultrasound, anatomically-obstructive coronary stenosis by CCTA demonstrates an unreliable relationship to lesion-specific ischemia. Recently, with the advance of imaging reconstruction and analysis technique, several novel parameters computed from CCTA were suggested to have added value in determining the ischemia-causing coronary stenosis. In this study, diagnostic performance of transluminal attenuation gradient (TAG) and fractional flow reserve computed form CCTA (FFR-CCTA) for the presence of hemodynamically-significant coronary stenosis, as determined by FFR, will be compared to suggest best functional parameter noninvasively computed form CCTA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or known coronary artery disease (CAD) who underwent coronary CT angiography, invasive coronary angiography, and fractional flow reserve measurement between May, 2010 and January, 2011
Key inclusion criteria (3 listed)
- Age >= 18 years old
- CCTA with >=50% stenosis in a major coronary artery (>=2.0 mm diameter)
- underwent invasive coronary angiography with FFR measurement
Key exclusion criteria (1 listed)
- with CCTA of poor image quality
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
fractional flow reserve
Time frame: 1day
fractional flow reserve of stenotic coronary artery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
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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?
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 1 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: status not confirmed, as of the sponsor's last update on 10 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bon-Kwon Koo, MD, PhD (82-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fractional flow reserve (time frame: 1day). 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 10 Aug 2011.