Diagnosis Coronary Artery DiseaseIMAGES-FFRNCT01400230
Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound
An observational study of Diagnosis Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic intra-luminal images. Read more about this study
- Who is it for?
- Ages 20 to 83 years
- Conditions the study is for
- Diagnosis Coronary Artery Disease
- What is being tested?
- diagnostic procedures CCTA, CAG, IVUS and FFR
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to 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 20 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who underwent CCTA, IVUS and FFR Stable clinical condition
Who may be able to join
- patients presenting chest pain suspected stable angina or unstable angina
- patients permit informed consents
- patients performed all the procedures including CCTA, IVUS and FFR and present coronary artery stenosis
Who cannot join
- acute myocardial infarction
- ejection fraction less than 40%
- infarct related artery
- chronic renal insufficiency
- left main stenosis, in-stent restenosis and grafted vessels
- allergy in contrast agent and adenosine
- unable to get a informed consents
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 411-706
About this study
Official title: Diagnostic Performances of the Computed Tomographic Coronary Angiography and IntraVascular UltraSound to Evaluate Ischemia Causing Coronary Artery Stenosis
Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess precise anatomical information. Optimal functional criteria and their accuracy of IVUS and CCTA by fraction flow reserve (FFR) have not been compared yet.
Read the detailed description
Correlation between CCTA, IVUS and FFR will be evaluated. The presence of myocardial ischemia will be assessed by fractional flow reserve (FFR).
Diagnostic performance (sensitivity, specificity, positive predictive/negative predictive values and diagnostic accuracy) of each modality will be assessed and compared.
- Conditions
- Diagnosis Coronary Artery Disease
- Being tested
- diagnostic procedures CCTA, CAG, IVUS and FFR
- Keywords
- computed tomography, intravascular ultrasound, coronary stenosis, fractional flow reserve
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic procedures CCTA, CAG, IVUS and FFRProcedure or surgery
Also called CCTA, Aquillion, Toshiba, IVUS, InVision Gold, Volcano and I-Lab, Boston, FFR, Pressure Wire, St.Jude medical
Diagnostic procedures including computed tomography, coronary angiography, intravascular ultrasound, fractional flow reserve were performed in the patients suspected ischemic heart disease.
| Study group | Role | What they receive |
|---|---|---|
| CCTA-IVUS-FFR | Patients suspected ischemic heart disease by the symptom and CCTA and undergone IVUS and FFR in the Cath Lab with CAG enrolled consecutively. Receives: Procedure: diagnostic procedures CCTA, CAG, IVUS and FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Evaluate and compare the diagnostic accuracy of the CCTA, IVUS and angiographic parameters for the prediction of myocardial ischemia (FFR<0.8)
- CCTA: % area stenosis
- IVUS: minimum lumen area
- Angiography: % diameter stenosis
Diagnostic accuracy of each parameter: (true positive+true negative)/total cases
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 posted22 Jul 2011 (estimated)
- Study startMar 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diagnosis 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Joon Hyung Doh, MD, PhD, Study director, Inje University Ilsan Paik HospitalBon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400230
- Sponsor's protocol ID
- IB-2-1010-049
- Acronym
- IMAGES-FFR
- Status last verified
- Mar 2015
- First submitted
- 15 Jul 2011
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nam CW, Yoon HJ, Cho YK, Park HS, Kim H, Hur SH, Kim YN, Chung IS, Koo BK, Tahk SJ, Fearon WF, Kim KB. Outcomes of percutaneous coronary intervention in intermediate coronary artery disease: fractional flow reserve-guided versus intravascular ultrasound-guided. JACC Cardiovasc Interv. 2010 Aug;3(8):812-7. doi: 10.1016/j.jcin.2010.04.016.
PubMed 20723852Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.
PubMed 21481828Ahn JM, Kang SJ, Mintz GS, Oh JH, Kim WJ, Lee JY, Park DW, Lee SW, Kim YH, Lee CW, Park SW, Moon DH, Park SJ. Validation of minimal luminal area measured by intravascular ultrasound for assessment of functionally significant coronary stenosis comparison with myocardial perfusion imaging. JACC Cardiovasc Interv. 2011 Jun;4(6):665-71. doi: 10.1016/j.jcin.2011.02.013.
PubMed 21700253Ben-Dor I, Torguson R, Gaglia MA Jr, Gonzalez MA, Maluenda G, Bui AB, Xue Z, Satler LF, Suddath WO, Lindsay J, Pichard AD, Waksman R. Correlation between fractional flow reserve and intravascular ultrasound lumen area in intermediate coronary artery stenosis. EuroIntervention. 2011 Jun;7(2):225-33. doi: 10.4244/EIJV7I2A37.
PubMed 21646065
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performances of the Computed Tomographic Coronary Angiography and IntraVascular UltraSound to Evaluate Ischemia Causing Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT01400230
- Acronym / sponsor ID
- IMAGES-FFR / IB-2-1010-049
- Conditions
- Diagnosis Coronary Artery Disease
- Keywords
- computed tomography, intravascular ultrasound, coronary stenosis, fractional flow reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Inje University
- Study start
- Mar 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jul 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.
Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess precise anatomical information. Optimal functional criteria and their accuracy of IVUS and CCTA by fraction flow reserve (FFR) have not been compared yet.
Detailed description
Correlation between CCTA, IVUS and FFR will be evaluated. The presence of myocardial ischemia will be assessed by fractional flow reserve (FFR).
Diagnostic performance (sensitivity, specificity, positive predictive/negative predictive values and diagnostic accuracy) of each modality will be assessed and compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA-IVUS-FFR | – | Procedure: diagnostic procedures CCTA, CAG, IVUS and FFRPatients suspected ischemic heart disease by the symptom and CCTA and undergone IVUS and FFR in the Cath Lab with CAG enrolled consecutively. |
Who may qualify
- Ages
- 20 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who underwent CCTA, IVUS and FFR Stable clinical condition
Key inclusion criteria (3 listed)
- patients presenting chest pain suspected stable angina or unstable angina
- patients permit informed consents
- patients performed all the procedures including CCTA, IVUS and FFR and present coronary artery stenosis
Key exclusion criteria (7 listed)
- acute myocardial infarction
- ejection fraction less than 40%
- infarct related artery
- chronic renal insufficiency
- left main stenosis, in-stent restenosis and grafted vessels
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 |
|---|---|---|
| diagnostic procedures CCTA, CAG, IVUS and FFRAlso: CCTA, Aquillion, Toshiba, IVUS, InVision Gold, Volcano and I-Lab, Boston, FFR, Pressure Wire, St.Jude medicalDiagnostic procedures including computed tomography, coronary angiography, intravascular ultrasound, fractional flow reserve were performed in the patients suspected ischemic heart disease. | Procedure or surgery | CCTA-IVUS-FFR |
Primary outcome
Diagnostic accuracy
Time frame: 1 day
Evaluate and compare the diagnostic accuracy of the CCTA, IVUS and angiographic parameters for the prediction of myocardial ischemia (FFR<0.8) 1. CCTA: % area stenosis 2. IVUS: minimum lumen area 3. Angiography: % diameter stenosis Diagnostic accuracy of each parameter: (true positive+true negative)/total cases
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 24 Mar 2015.
- Background: PubMed 20723852Nam CW, Yoon HJ, Cho YK, Park HS, Kim H, Hur SH, Kim YN, Chung IS, Koo BK, Tahk SJ, Fearon WF, Kim KB. Outcomes of percutaneous coronary intervention in intermediate coronary artery disease: fractional flow reserve-guided versus intravascular ultrasound-guided. JACC Cardiovasc Interv. 2010 Aug;3(8):812-7. doi: 10.1016/j.jcin.2010.04.016.
- Results publication: PubMed 21481828Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.
- Results publication: PubMed 21700253Ahn JM, Kang SJ, Mintz GS, Oh JH, Kim WJ, Lee JY, Park DW, Lee SW, Kim YH, Lee CW, Park SW, Moon DH, Park SJ. Validation of minimal luminal area measured by intravascular ultrasound for assessment of functionally significant coronary stenosis comparison with myocardial perfusion imaging. JACC Cardiovasc Interv. 2011 Jun;4(6):665-71. doi: 10.1016/j.jcin.2011.02.013.
- Results publication: PubMed 21646065Ben-Dor I, Torguson R, Gaglia MA Jr, Gonzalez MA, Maluenda G, Bui AB, Xue Z, Satler LF, Suddath WO, Lindsay J, Pichard AD, Waksman R. Correlation between fractional flow reserve and intravascular ultrasound lumen area in intermediate coronary artery stenosis. EuroIntervention. 2011 Jun;7(2):225-33. doi: 10.4244/EIJV7I2A37.
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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.
Joon Hyung Doh, MD, PhD study director
Inje University Ilsan Paik Hospital
Bon-Kwon Koo, MD, PhD principal investigator
Seoul National University Hospital
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 Diagnosis 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 7 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 24 Mar 2015. 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?
Diagnostic accuracy (time frame: 1 day). 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 NCT01400230, which also lists 4 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 24 Mar 2015.