To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic PlaqueNCT01857687

Evaluation of FFR, WSS, and TPF Using CCTA

An observational study of To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic Plaque, run by Seoul National University Hospital at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

To assess the feasibility of CT-derived computed fractional flow reserve (FFRCT), wall shear stress and total plaque force on coronary atherosclerotic plaque and to collect the preliminary data to apply those parameters for the prediction of clinical outcomes in patients with coronary artery stenosis. Read more about this study

Who is it for?: Any age
Conditions the study is for: To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic Plaque
How many people: 100 participants
Where: 2 sitesSouth Korea
Study dates: May 2013to May 2014
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: patients with coronary artery stenosis

Who may be able to join

Consecutive patients with available CCTA within 3 months of invasive angiography and invasive imaging methods (IVUS or OCT)

Who cannot join

Poor CT images (unable to reconstruct 3 dimensional coronary artery model)

Trial locations and contacts

2 sites in 1 country.

Bon-Kwon Koo, MD, PhD contact

82-2-2072-2062

bkkoo@snu.ac.kr

South Korea2 sites, 1 recruiting

Seoul National University hospital
Seoul, 110744
Bon-Kwon Koo
Recruiting
Seoul National University Hospital
Seoul
Active, not recruiting

Other trials in South Korea

About this study

Official title: Noninvasive Evaluation of Ischemia Causing Coronary Stenosis, Wall Shear Stress, and Total Plaque Force Using Coronary CT Angiography (CCTA) and Physics-based Analytic Model Derived From Conservation of Energy

Conditions: To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01857687
Study group	Role	What they receive
patients with coronary artery stenosis		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

CT-derived computed fractional flow reserve
Measured: at time of evaulation

Secondary outcomes (2)

wall shear stress
Measured: at time of evaulation
total plaque force
Measured: at time of evaulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013May 2014

First posted20 May 2013 (estimated)
Study startMay 2013
Primary completionMay 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic PlaqueStudies 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: Retrospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01857687
Sponsor's protocol ID: SNUH CT-FFR WSS TPF
Status last verified: Nov 2013
First submitted: 16 May 2013
Last updated: 27 Nov 2013
Results posted: No

Publications

Fearon WF, Bornschein B, Tonino PA, Gothe RM, Bruyne BD, Pijls NH, Siebert U; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) Study Investigators. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010 Dec 14;122(24):2545-50. doi: 10.1161/CIRCULATIONAHA.109.925396. Epub 2010 Nov 29.
PubMed 21126973
Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
PubMed 20537493
Wong JT, Le H, Suh WM, Chalyan DA, Mehraien T, Kern MJ, Kassab GS, Molloi S. Quantification of fractional flow reserve based on angiographic image data. Int J Cardiovasc Imaging. 2012 Jan;28(1):13-22. doi: 10.1007/s10554-010-9767-0. Epub 2011 Jan 7.
PubMed 21213051
Hamon M, Biondi-Zoccai GG, Malagutti P, Agostoni P, Morello R, Valgimigli M, Hamon M. Diagnostic performance of multislice spiral computed tomography of coronary arteries as compared with conventional invasive coronary angiography: a meta-analysis. J Am Coll Cardiol. 2006 Nov 7;48(9):1896-910. doi: 10.1016/j.jacc.2006.08.028. Epub 2006 Sep 26.
PubMed 17084268
Achenbach S, Moselewski F, Ropers D, Ferencik M, Hoffmann U, MacNeill B, Pohle K, Baum U, Anders K, Jang IK, Daniel WG, Brady TJ. Detection of calcified and noncalcified coronary atherosclerotic plaque by contrast-enhanced, submillimeter multidetector spiral computed tomography: a segment-based comparison with intravascular ultrasound. Circulation. 2004 Jan 6;109(1):14-7. doi: 10.1161/01.CIR.0000111517.69230.0F. Epub 2003 Dec 22.
PubMed 14691045
Leber AW, Knez A, von Ziegler F, Becker A, Nikolaou K, Paul S, Wintersperger B, Reiser M, Becker CR, Steinbeck G, Boekstegers P. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography and intravascular ultrasound. J Am Coll Cardiol. 2005 Jul 5;46(1):147-54. doi: 10.1016/j.jacc.2005.03.071.
PubMed 15992649
Koo 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
Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
PubMed 22922562
Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25.
PubMed 21788584
Stone PH, Saito S, Takahashi S, Makita Y, Nakamura S, Kawasaki T, Takahashi A, Katsuki T, Nakamura S, Namiki A, Hirohata A, Matsumura T, Yamazaki S, Yokoi H, Tanaka S, Otsuji S, Yoshimachi F, Honye J, Harwood D, Reitman M, Coskun AU, Papafaklis MI, Feldman CL; PREDICTION Investigators. Prediction of progression of coronary artery disease and clinical outcomes using vascular profiling of endothelial shear stress and arterial plaque characteristics: the PREDICTION Study. Circulation. 2012 Jul 10;126(2):172-81. doi: 10.1161/CIRCULATIONAHA.112.096438. Epub 2012 Jun 21.
PubMed 22723305
Choi G, Lee JM, Kim HJ, Park JB, Sankaran S, Otake H, Doh JH, Nam CW, Shin ES, Taylor CA, Koo BK. Coronary Artery Axial Plaque Stress and its Relationship With Lesion Geometry: Application of Computational Fluid Dynamics to Coronary CT Angiography. JACC Cardiovasc Imaging. 2015 Oct;8(10):1156-1166. doi: 10.1016/j.jcmg.2015.04.024. Epub 2015 Sep 9.
PubMed 26363834

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Noninvasive Evaluation of Ischemia Causing Coronary Stenosis, Wall Shear Stress, and Total Plaque Force Using Coronary CT Angiography (CCTA) and Physics-based Analytic Model Derived From Conservation of Energy
ClinicalTrials.gov ID: NCT01857687
Acronym / sponsor ID: SNUH CT-FFR WSS TPF
Conditions: To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic Plaque
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: May 2013
Primary completion: May 2014 (estimated)
First posted: 20 May 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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
patients with coronary artery stenosis	–	–

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: patients with coronary artery stenosis

Key inclusion criteria (1 listed)

Consecutive patients with available CCTA within 3 months of invasive angiography and invasive imaging methods (IVUS or OCT)

Key exclusion criteria (1 listed)

Poor CT images (unable to reconstruct 3 dimensional coronary artery model)

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

CT-derived computed fractional flow reserve
Time frame: at time of evaulation

2 secondary outcomes

wall shear stress
Time frame: at time of evaulation
total plaque force
Time frame: at time of evaulation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Background: PubMed 21126973Fearon WF, Bornschein B, Tonino PA, Gothe RM, Bruyne BD, Pijls NH, Siebert U; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) Study Investigators. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010 Dec 14;122(24):2545-50. doi: 10.1161/CIRCULATIONAHA.109.925396. Epub 2010 Nov 29.
Background: PubMed 20537493Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
Background: PubMed 21213051Wong JT, Le H, Suh WM, Chalyan DA, Mehraien T, Kern MJ, Kassab GS, Molloi S. Quantification of fractional flow reserve based on angiographic image data. Int J Cardiovasc Imaging. 2012 Jan;28(1):13-22. doi: 10.1007/s10554-010-9767-0. Epub 2011 Jan 7.
Background: PubMed 17084268Hamon M, Biondi-Zoccai GG, Malagutti P, Agostoni P, Morello R, Valgimigli M, Hamon M. Diagnostic performance of multislice spiral computed tomography of coronary arteries as compared with conventional invasive coronary angiography: a meta-analysis. J Am Coll Cardiol. 2006 Nov 7;48(9):1896-910. doi: 10.1016/j.jacc.2006.08.028. Epub 2006 Sep 26.
Background: PubMed 14691045Achenbach S, Moselewski F, Ropers D, Ferencik M, Hoffmann U, MacNeill B, Pohle K, Baum U, Anders K, Jang IK, Daniel WG, Brady TJ. Detection of calcified and noncalcified coronary atherosclerotic plaque by contrast-enhanced, submillimeter multidetector spiral computed tomography: a segment-based comparison with intravascular ultrasound. Circulation. 2004 Jan 6;109(1):14-7. doi: 10.1161/01.CIR.0000111517.69230.0F. Epub 2003 Dec 22.
Background: PubMed 15992649Leber AW, Knez A, von Ziegler F, Becker A, Nikolaou K, Paul S, Wintersperger B, Reiser M, Becker CR, Steinbeck G, Boekstegers P. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography and intravascular ultrasound. J Am Coll Cardiol. 2005 Jul 5;46(1):147-54. doi: 10.1016/j.jacc.2005.03.071.
Background: 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.
Background: PubMed 22922562Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
Background: PubMed 21788584Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25.
Background: PubMed 22723305Stone PH, Saito S, Takahashi S, Makita Y, Nakamura S, Kawasaki T, Takahashi A, Katsuki T, Nakamura S, Namiki A, Hirohata A, Matsumura T, Yamazaki S, Yokoi H, Tanaka S, Otsuji S, Yoshimachi F, Honye J, Harwood D, Reitman M, Coskun AU, Papafaklis MI, Feldman CL; PREDICTION Investigators. Prediction of progression of coronary artery disease and clinical outcomes using vascular profiling of endothelial shear stress and arterial plaque characteristics: the PREDICTION Study. Circulation. 2012 Jul 10;126(2):172-81. doi: 10.1161/CIRCULATIONAHA.112.096438. Epub 2012 Jun 21.
Derived from this study: PubMed 26363834Choi G, Lee JM, Kim HJ, Park JB, Sankaran S, Otake H, Doh JH, Nam CW, Shin ES, Taylor CA, Koo BK. Coronary Artery Axial Plaque Stress and its Relationship With Lesion Geometry: Application of Computational Fluid Dynamics to Coronary CT Angiography. JACC Cardiovasc Imaging. 2015 Oct;8(10):1156-1166. doi: 10.1016/j.jcmg.2015.04.024. Epub 2015 Sep 9.

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 contact

82-2-2072-2062

bkkoo@snu.ac.kr

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic Plaque, run by Seoul National University Hospital at 2 sites 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 1 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 27 Nov 2013. 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 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 (82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CT-derived computed fractional flow reserve (time frame: at time of evaulation). 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 NCT01857687, which also lists 11 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 27 Nov 2013.