Impact of Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes
NCT ID: NCT04547231
Last Updated: 2021-03-23
Study Results
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Basic Information
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RECRUITING
992 participants
OBSERVATIONAL
2020-08-12
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Deferral of PCI group
Patients with a vessel determined to defer revascularization after FFR measurement who undergo CCTA within 90 days before FFR measurement will be included.
Fractional flow reserve, Coronary CT angiography
1. Coronary CT angiography (CCTA) and measurement of fractional flow reserve (FFR) will be performed as part of routine clinical practice. The decision to perform CCTA before invasive angiography was at the judgment of the physicians in charge.
2. Physiologic assessment includes delta FFR (lesion-specific) and FFR (vessel-specific) measurement. Delta FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).
3. Stenosis and plaque features on CCTA will be analyzed by an independent CCTA core laboratory (Severance Cardiovascular Hospital, Seoul, Korea), and pericoronary and epicardial fat metrics (fat attenuation index, epicardial fat attenuation index, epicardial fat volume, etc.) will be obtained by an independent cardiac CT fat core laboratory (Tsuchiura Kyodo general hospital, Ibaraki, Japan).
PCI group
Patients with a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR) with available coronary CT angiography within 90 days before FFR measurement will be included.
Fractional flow reserve, Coronary CT angiography
1. Coronary CT angiography (CCTA) and measurement of fractional flow reserve (FFR) will be performed as part of routine clinical practice. The decision to perform CCTA before invasive angiography was at the judgment of the physicians in charge.
2. Physiologic assessment includes delta FFR (lesion-specific) and FFR (vessel-specific) measurement. Delta FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).
3. Stenosis and plaque features on CCTA will be analyzed by an independent CCTA core laboratory (Severance Cardiovascular Hospital, Seoul, Korea), and pericoronary and epicardial fat metrics (fat attenuation index, epicardial fat attenuation index, epicardial fat volume, etc.) will be obtained by an independent cardiac CT fat core laboratory (Tsuchiura Kyodo general hospital, Ibaraki, Japan).
Interventions
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Fractional flow reserve, Coronary CT angiography
1. Coronary CT angiography (CCTA) and measurement of fractional flow reserve (FFR) will be performed as part of routine clinical practice. The decision to perform CCTA before invasive angiography was at the judgment of the physicians in charge.
2. Physiologic assessment includes delta FFR (lesion-specific) and FFR (vessel-specific) measurement. Delta FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).
3. Stenosis and plaque features on CCTA will be analyzed by an independent CCTA core laboratory (Severance Cardiovascular Hospital, Seoul, Korea), and pericoronary and epicardial fat metrics (fat attenuation index, epicardial fat attenuation index, epicardial fat volume, etc.) will be obtained by an independent cardiac CT fat core laboratory (Tsuchiura Kyodo general hospital, Ibaraki, Japan).
Eligibility Criteria
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Inclusion Criteria
2. Patients who undergo CCTA within 90 days before FFR measurement by clinical needs
3. Patients with a vessel determined to defer revascularization after FFR measurement.
1. Age ≥ 20 years
2. Patients who undergo CCTA within 90 days before FFR measurement by clinical needs
3. Patients with a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR).
Exclusion Criteria
2. Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
3. Abnormal epicardial coronary flow (TIMI flow \< 3)
4. Failed FFR measurement
5. Planned coronary artery bypass graft surgery after diagnostic angiography
6. Poor quality of CCTA which is unsuitable for plaque analysis
7. Patients with a stent in the target vessel
2\) PCI group
1. Left ventricular ejection fraction \< 35%
2. Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
3. Abnormal epicardial coronary flow (TIMI flow \< 3)
4. Failed FFR measurement
5. Planned coronary artery bypass graft surgery after diagnostic angiography
6. Poor quality of CCTA which is unsuitable for plaque analysis
7. Patients with a stent in the target vessel
20 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Ulsan Hospital
UNKNOWN
Inje University
OTHER
Sejong General Hospital
OTHER
Chosun University Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Dong-A University Hospital
OTHER
Wonju Severance Christian Hospital
OTHER
Incheon St.Mary's Hospital
OTHER
Tsuchiura Kyodo General Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Dong-A ST Co., Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Bon-Kwon Koo
Professor
Principal Investigators
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Bon-Kwon Koo, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Select, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hwang D, Park J, Kim KJ, Zhang J, Hu X, Wang J, Ahn C, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Clinical implications of three-vessel fractional flow reserve measurement in patients with coronary artery disease. Eur Heart J. 2018 Mar 14;39(11):945-951. doi: 10.1093/eurheartj/ehx458.
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Driessen RS, Stuijfzand WJ, Raijmakers PG, Danad I, Min JK, Leipsic JA, Ahmadi A, Narula J, van de Ven PM, Huisman MC, Lammertsma AA, van Rossum AC, van Royen N, Knaapen P. Effect of Plaque Burden and Morphology on Myocardial Blood Flow and Fractional Flow Reserve. J Am Coll Cardiol. 2018 Feb 6;71(5):499-509. doi: 10.1016/j.jacc.2017.11.054.
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Other Identifiers
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H-2007-201-1144
Identifier Type: -
Identifier Source: org_study_id
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