Evaluation of FFR, WSS, and TPF Using CCTA
Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01857687
Collaborator
(none)
100
2
50
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Study Start Date
:
May 1, 2013
Anticipated Primary Completion Date
:
May 1, 2014
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
patients with coronary artery stenosis
|
Outcome Measures
Primary Outcome Measures
- CT-derived computed fractional flow reserve [at time of evaulation]
Secondary Outcome Measures
- wall shear stress [at time of evaulation]
- total plaque force [at time of evaulation]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Consecutive patients with available CCTA within 3 months of invasive angiography and invasive imaging methods (IVUS or OCT)
Exclusion Criteria:
- Poor CT images (unable to reconstruct 3 dimensional coronary artery model)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Seoul National University hospital | Seoul | Korea, Republic of | 110744 | |
2 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2003 Dec 22.
- 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.
- 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. Epub 2006 Sep 26. Review.
- 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.
- 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.
- 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.
- Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrøm 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.
- 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.
- 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.
- 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.
Responsible Party:
Bon-Kwon Koo,
Associate Professor of Medicine / Cardiology,
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01857687
Other Study ID Numbers:
- SNUH CT-FFR WSS TPF
First Posted:
May 20, 2013
Last Update Posted:
Nov 27, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms: