CCTA-FFR Registry for Risk Prediction

NCT04037163 | Completed DMC

• 1 other identifier: H-1907-094-1048
• Study Type: observational
• Target: 747
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators sought to investigate the prognostic implication of qualitative and quantitative plaque analysis on coronary CT angiography (CCTA) according to fractional flow reserve (FFR). The main objective was to develop a comprehensive risk model by using clinical risk factors, FFR and CCTA parameters.

Conditions

Coronary Artery Disease

Keywords

Fractional flow reserve; Coronary CT angiography; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Discrimination index of prediction model for vessel-oriented composite outcome

  A risk model for vessel-oriented composite outcome, incorporating clinical, angiographic, fractional flow reserve (FFR), and coronary CT angiographic parameters will be developed. Vessel-oriented composite outcome is a composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization. The target vessel will be defined as the vessel with FFR measurement.

  Upto 5 years after index procedure

Study Arms (1)

CCTA-FFR

Patients who underwent CCTA within 90 days before FFR measurement will be included in the present study.

Diagnostic Test: Fractional flow reserve, Coronary CT angiography

Interventions

Fractional flow reserve, Coronary CT angiography DIAGNOSTIC_TEST

Coronary CT angiography was performed as part of routine clinical practice for patients with suspected coronary artery disease and the decision to perform coronary CT angiography before invasive angiography was at the judgment of the physicians in charge.

CCTA-FFR

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected coronary artery disease who underwent coronary CT angiography within 90 days before FFR measurement will be included.

You may qualify if:

• Patients who underwent CCTA within 90 days before FFR measurement

You may not qualify if:

• Unanalyzable coronary CT angiography
• Inadequate fractional flow reserve measurement

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Keimyung University Dongsan Medical Center: collaborator
• Inje University: collaborator
• Tsuchiura Kyodo General Hospital: collaborator

Related Publications (16)

• Nielsen LH, Botker HE, Sorensen HT, Schmidt M, Pedersen L, Sand NP, Jensen JM, Steffensen FH, Tilsted HH, Bottcher M, Diederichsen A, Lambrechtsen J, Kristensen LD, Ovrehus KA, Mickley H, Munkholm H, Gotzsche O, Husain M, Knudsen LL, Norgaard BL. Prognostic assessment of stable coronary artery disease as determined by coronary computed tomography angiography: a Danish multicentre cohort study. Eur Heart J. 2017 Feb 7;38(6):413-421. doi: 10.1093/eurheartj/ehw548.

  PMID: 27941018 BACKGROUND

• Cho I, Al'Aref SJ, Berger A, O Hartaigh B, Gransar H, Valenti V, Lin FY, Achenbach S, Berman DS, Budoff MJ, Callister TQ, Al-Mallah MH, Cademartiri F, Chinnaiyan K, Chow BJW, DeLago A, Villines TC, Hadamitzky M, Hausleiter J, Leipsic J, Shaw LJ, Kaufmann PA, Feuchtner G, Kim YJ, Maffei E, Raff G, Pontone G, Andreini D, Marques H, Rubinshtein R, Chang HJ, Min JK. Prognostic value of coronary computed tomographic angiography findings in asymptomatic individuals: a 6-year follow-up from the prospective multicentre international CONFIRM study. Eur Heart J. 2018 Mar 14;39(11):934-941. doi: 10.1093/eurheartj/ehx774.

  PMID: 29365193 BACKGROUND

• SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.

  PMID: 30145934 BACKGROUND

• Motoyama S, Ito H, Sarai M, Kondo T, Kawai H, Nagahara Y, Harigaya H, Kan S, Anno H, Takahashi H, Naruse H, Ishii J, Hecht H, Shaw LJ, Ozaki Y, Narula J. Plaque Characterization by Coronary Computed Tomography Angiography and the Likelihood of Acute Coronary Events in Mid-Term Follow-Up. J Am Coll Cardiol. 2015 Jul 28;66(4):337-46. doi: 10.1016/j.jacc.2015.05.069.

  PMID: 26205589 BACKGROUND

• Williams MC, Moss AJ, Dweck M, Adamson PD, Alam S, Hunter A, Shah ASV, Pawade T, Weir-McCall JR, Roditi G, van Beek EJR, Newby DE, Nicol ED. Coronary Artery Plaque Characteristics Associated With Adverse Outcomes in the SCOT-HEART Study. J Am Coll Cardiol. 2019 Jan 29;73(3):291-301. doi: 10.1016/j.jacc.2018.10.066.

  PMID: 30678759 BACKGROUND

• De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.

  PMID: 8124786 BACKGROUND

• Berger A, Botman KJ, MacCarthy PA, Wijns W, Bartunek J, Heyndrickx GR, Pijls NH, De Bruyne B. Long-term clinical outcome after fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. J Am Coll Cardiol. 2005 Aug 2;46(3):438-42. doi: 10.1016/j.jacc.2005.04.041.

  PMID: 16053955 BACKGROUND

• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

  PMID: 19144937 BACKGROUND

• Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. doi: 10.1161/01.cir.87.4.1354.

  PMID: 8462157 BACKGROUND

• Park J, Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hwang D, Zhang J, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Clinical Relevance of Functionally Insignificant Moderate Coronary Artery Stenosis Assessed by 3-Vessel Fractional Flow Reserve Measurement. J Am Heart Assoc. 2018 Feb 15;7(4):e008055. doi: 10.1161/JAHA.117.008055.

  PMID: 29449274 BACKGROUND

• Kim CH, Yang S, Zhang J, Lee JM, Hoshino M, Murai T, Hwang D, Shin ES, Doh JH, Nam CW, Wang J, Chen SL, Tanaka N, Matsuo H, Akasaka T, Kakuta T, Koo BK. Differences in Plaque Characteristics and Myocardial Mass: Implications for Physiological Significance. JACC Asia. 2022 Mar 29;2(2):157-167. doi: 10.1016/j.jacasi.2021.11.011. eCollection 2022 Apr.

  PMID: 36339124 DERIVED

• Yang S, Lee JM, Hoshino M, Murai T, Choi KH, Hwang D, Kim KJ, Shin ES, Doh JH, Chang HJ, Nam CW, Zhang J, Wang J, Chen SL, Tanaka N, Matsuo H, Akasaka T, Kakuta T, Koo BK. Prognostic Implications of Comprehensive Whole Vessel Plaque Quantification Using Coronary Computed Tomography Angiography. JACC Asia. 2021 Jun 15;1(1):37-48. doi: 10.1016/j.jacasi.2021.05.003. eCollection 2021 Jun.

  PMID: 36338359 DERIVED

• Yang S, Hoshino M, Yonetsu T, Zhang J, Hwang D, Shin ES, Doh JH, Nam CW, Wang J, Chen S, Tanaka N, Matsuo H, Kubo T, Chang HJ, Kakuta T, Koo BK. Outcomes of non-ischaemic coronary lesions with high-risk plaque characteristics on coronary CT angiography. EuroIntervention. 2023 Jan 23;18(12):1011-1021. doi: 10.4244/EIJ-D-22-00562.

  PMID: 36222756 DERIVED

• Yang S, Hoshino M, Koo BK, Yonetsu T, Zhang J, Hwang D, Shin ES, Doh JH, Nam CW, Wang J, Chen S, Tanaka N, Matsuo H, Kubo T, Chang HJ, Kakuta T, Narula J. Relationship of Plaque Features at Coronary CT to Coronary Hemodynamics and Cardiovascular Events. Radiology. 2022 Dec;305(3):578-587. doi: 10.1148/radiol.213271. Epub 2022 Aug 16.

  PMID: 35972355 DERIVED

• Yang S, Koo BK, Hwang D, Zhang J, Hoshino M, Lee JM, Murai T, Park J, Shin ES, Doh JH, Nam CW, Wang J, Chen S, Tanaka N, Matsuo H, Akasaka T, Chang HJ, Kakuta T, Narula J. High-Risk Morphological and Physiological Coronary Disease Attributes as Outcome Markers After Medical Treatment and Revascularization. JACC Cardiovasc Imaging. 2021 Oct;14(10):1977-1989. doi: 10.1016/j.jcmg.2021.04.004. Epub 2021 May 19.

  PMID: 34023270 DERIVED

• Yang S, Koo BK, Hoshino M, Lee JM, Murai T, Park J, Zhang J, Hwang D, Shin ES, Doh JH, Nam CW, Wang J, Chen S, Tanaka N, Matsuo H, Akasaka T, Choi G, Petersen K, Chang HJ, Kakuta T, Narula J. CT Angiographic and Plaque Predictors of Functionally Significant Coronary Disease and Outcome Using Machine Learning. JACC Cardiovasc Imaging. 2021 Mar;14(3):629-641. doi: 10.1016/j.jcmg.2020.08.025. Epub 2020 Nov 25.

  PMID: 33248965 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

• Joon Hyung Doh, MD, PhD

  Inje University

  PRINCIPAL INVESTIGATOR

• Chang-Wook Nam, MD, PhD

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

• Tsunekazu Kakuta, MD, PhD

  Tsuchiura Kyodo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 30, 2019
• Study Start: December 22, 2010
• Primary Completion: March 31, 2019
• Study Completion: May 31, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share