Coronary Artery DiseasePRIME-CTNCT04547231

Impact of Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes

An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The investigators aim to investigate the prognostic implication of stenosis and plaque features on coronary CT angiography (CCTA), physiologic assessment, and pharmacotherapy after invasive coronary angiography. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Fractional flow reserve, Coronary CT angiography
How many people: 992 participants
Where: 1 siteSouth Korea
Study dates: 12 Aug 2020to 31 Dec 2025
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 years and older
All sexes
Adult, Older adult

Study population: Patients with suspected coronary artery disease who underwent CCTA within 90 days before FFR measurement will be included. If the patients receive PCI after FFR measurement, those with available both preprocedural and postprocedural FFR measurement will be included.

Who may be able to join

Age ≥ 20 years
Patients who undergo CCTA within 90 days before FFR measurement by clinical needs
Patients with a vessel determined to defer revascularization after FFR measurement.
Age ≥ 20 years
Patients who undergo CCTA within 90 days before FFR measurement by clinical needs
Patients with a vessel that undergo stent implantation and FFR measurement both before and after revascularization (pre-PCI FFR and post-PCI FFR).
Patients with multiple vessels that meet inclusion criteria of the deferral of PCI group and PCI group will be assigned to the PCI group.

Who cannot join

Left ventricular ejection fraction < 35%
Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
Abnormal epicardial coronary flow (TIMI flow < 3)
Failed FFR measurement
Planned coronary artery bypass graft surgery after diagnostic angiography
Poor quality of CCTA which is unsuitable for plaque analysis

Show all 15Show fewer

Patients with a stent in the target vessel
2) PCI group
Left ventricular ejection fraction < 35%
Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
Abnormal epicardial coronary flow (TIMI flow < 3)
Failed FFR measurement
Planned coronary artery bypass graft surgery after diagnostic angiography
Poor quality of CCTA which is unsuitable for plaque analysis
Patients with a stent in the target vessel

Trial locations and contacts

1 site in 1 country.

Bon-Kwon Koo, MD, PhD contact

+82-1033561869

bkkoo@snu.ac.kr

Seokhun Yang, MD contact

+82-1025953470

newturnz7@gmail.com

South Korea1 site, 1 recruiting

Seoul National University Hospital
Seoul, Select, 03080
Bon-Kwon Koo, MD, PhD, +82-1033561869, bkkoo@snu.ac.kr
Seokhun Yang, MD, +82-1025953470, newturnz7@gmail.com
Recruiting

Other trials in South Korea

About this study

Official title: Impact of Stenosis and Plaque Features in Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes After Invasive Coronary Angiography

Read the detailed description

Stenosis severity, plaque features, and myocardial ischemia have been known as important indicators in diagnosis and prognostication of patients with coronary artery disease. Invasive physiologic indies such as fractional flow reserve (FFR) are used to define ischemia-causing stenosis in the catheterization laboratory. FFR represents maximal blood flow to the myocardium supplied by an artery with stenosis as a fraction of normal maximum flow. The FFR-guided strategy was reported to improve the patients' outcomes in comparison with the angiography-guided strategy. However, clinical events still occur in patients with FFR >0.80, and invasive therapy did not improve prognosis in patients with moderate to severe ischemia compared to optimal medical therapy in the ISCHEMIA trial. In the recent report, the prognosis in the vessel with FFR >0.80 was associated with high-risk plaque characteristics on coronary CT angiography (CCTA). Likewise, incorporation of stenosis and plaque features and myocardial ischemia may provide better risk stratification of patients with coronary artery disease than evaluating each attribute alone. Recent proposed novel measurement such as pericoronary inflammation or epicardial fat metrics and lesion-specific or vessel-specific hemodynamic parameters derived from CCTA has also been known as a robust prognostic predictor. In addition, antiplatelet agents and lipid-lowering medication such as aspirin, clopidogrel, or statin are commonly used for primary and secondary prevention of adverse cardiovascular events. However, the relationship of combination and dosage of those drugs with prevention of plaque progression and clinical outcomes has not been fully understood. Accordingly, the investigators aim to find the prognostic implications of stenosis and plaque features, fat metrics on CCTA along with physiologic assessment and pharmocotherapy according to the different treatment strategies.

Conditions: Coronary Artery Disease
Being tested: Fractional flow reserve, Coronary CT angiography
Keywords: Coronary Artery Disease, Coronary CT angiography, Atherosclerosis, Fractional Flow Reserve, Clinical outcome, Pharmacotherapy, Percutaneous coronary intervention
Medical subject headings: Coronary Artery Disease, Atherosclerosis

What participants receive

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

Fractional flow reserve, Coronary CT angiographyDiagnostic test
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).

Study groups in NCT04547231
Study group	Role	What they receive
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. Receives: Diagnostic Test: Fractional flow reserve, Coronary CT angiography
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. Receives: Diagnostic Test: Fractional flow reserve, Coronary CT angiography

What is being measured

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

Adverse cardiovascular event according to stenosis and plaque features (Deferral group).
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.
Measured: Upto 2 years after index procedure
Adverse cardiovascular event according to pre-PCI FFR in vessels with low post-PCI FFR (PCI group).
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.
Measured: Upto 2 years after index procedure

Secondary outcomes (13)

Additive prognostic value of stenosis and plaque features on CCTA over FFR in prediction of adverse cardiovascular events (Deferral group).
Comparison of outcome discrimination ability.
Measured: Upto 2 years after index procedure
Comprehensive risk prediction model by integrating stenosis and plaque features, local hemodynamic parameters (Deferral group).
Risk prediction model using conventional statistics or machine learning.
Measured: Upto 2 years after index procedure
Clinical events and plaque and physiologic characteristics by medication history including antiplatelet agents and statin and serum lipid level during follow-up (Deferral group).
Changes in lesion characteristics and outcome by medication history.
Measured: Upto 2 years after index procedure
Prognostic value of CT-defined pericoronary and epicardial fat metrics (fat attenuation index [FAI], epicardial fat attenuation index [EFAI], and epicardial fat volume [EFV]) (Deferral group).
Prognostic implications of fat metrics.
Measured: Upto 2 years after index procedure
Risk prediction model by stenosis and plaque features, local hemodynamic parameters, and fat metrics and physiologic assessment (delta FFR and FFR) (Deferral group).
Risk prediction model using conventional statistics or machine learning.
Measured: Upto 2 years after index procedure
Risk of adverse cardiovascular events according to pre-PCI FFR (PCI group).
Prognostic implications of pre-PCI FFR after PCI.
Measured: Upto 2 years after index procedure
Prognostic impact of stenosis and plaque features on CCTA, local hemodynamic parameters (PCI group).
Prognostic implications of stenosis and plaque features on CCTA after PCI.
Measured: Upto 2 years after index procedure
Comprehensive risk prediction model by integrating stenosis and plaque features on CCTA and physiologic assessment before and after PCI (PCI group).
Risk prediction model using conventional statistics or machine learning.
Measured: Upto 2 years after index procedure
Clinical events and plaque and physiologic characteristics by medication history including antiplatelet agents and statin and serum lipid level during follow-up (PCI group).
Changes in lesion characteristics and outcome by medication history.
Measured: Upto 2 years after index procedure
Prognostic value of CT-defined pericoronary and epicardial fat metrics (FAI, EFAI, EFV) (PCI group).
Prognostic implications of fat metrics.
Measured: Upto 2 years after index procedure
Risk prediction model by stenosis and plaque features, local hemodynamic parameters, and fat metrics and physiologic assessment (delta FFR and FFR) (PCI group).
Risk prediction model using conventional statistics or machine learning.
Measured: Upto 2 years after index procedure
Comparison of risk for future events by comprehensive CCTA analysis and physiologic assessment between the deferral of PCI and PCI group (Whole population).
Risk comparison and prediction model using conventional statistics or machine learning.
Measured: Upto 2 years after index procedure
Relationship among FFR values, CT-derived plaque qualification and quantification, and CT-defined pericoronary and epicardial fat metrics including FAI, EFAI, and EFV (Whole population).
Association among CCTA parameters and physiologic indices.
Measured: Upto 2 years after index procedure

Timeline

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

12 Aug 202031 Dec 2025

First posted14 Sep 2020
Study start12 Aug 2020
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for 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: 992 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04547231
Sponsor's protocol ID: H-2007-201-1144
Acronym: PRIME-CT
Status last verified: Mar 2021
First submitted: 7 Sep 2020
Last updated: 23 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The sharing plan will be decided by the study committee

Publications

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.
PubMed 21247313
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.
PubMed 29020260
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.
PubMed 26205589
Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
PubMed 8637515
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.
PubMed 19144937
Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.
PubMed 29785878
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
PubMed 32227755
Lee JM, Choi KH, Koo BK, Park J, Kim J, Hwang D, Rhee TM, Kim HY, Jung HW, Kim KJ, Yoshiaki K, Shin ES, Doh JH, Chang HJ, Cho YK, Yoon HJ, Nam CW, Hur SH, Wang J, Chen S, Kuramitsu S, Tanaka N, Matsuo H, Akasaka T. Prognostic Implications of Plaque Characteristics and Stenosis Severity in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2019 May 21;73(19):2413-2424. doi: 10.1016/j.jacc.2019.02.060.
PubMed 31097161
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.
PubMed 29406855
Gaur S, Ovrehus KA, Dey D, Leipsic J, Botker HE, Jensen JM, Narula J, Ahmadi A, Achenbach S, Ko BS, Christiansen EH, Kaltoft AK, Berman DS, Bezerra H, Lassen JF, Norgaard BL. Coronary plaque quantification and fractional flow reserve by coronary computed tomography angiography identify ischaemia-causing lesions. Eur Heart J. 2016 Apr 14;37(15):1220-7. doi: 10.1093/eurheartj/ehv690. Epub 2016 Jan 12.
PubMed 26763790
Ahmadi A, Leipsic J, Ovrehus KA, Gaur S, Bagiella E, Ko B, Dey D, LaRocca G, Jensen JM, Botker HE, Achenbach S, De Bruyne B, Norgaard BL, Narula J. Lesion-Specific and Vessel-Related Determinants of Fractional Flow Reserve Beyond Coronary Artery Stenosis. JACC Cardiovasc Imaging. 2018 Apr;11(4):521-530. doi: 10.1016/j.jcmg.2017.11.020. Epub 2018 Jan 5.
PubMed 29311033
Hwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041.
PubMed 32703590
Oikonomou EK, Marwan M, Desai MY, Mancio J, Alashi A, Hutt Centeno E, Thomas S, Herdman L, Kotanidis CP, Thomas KE, Griffin BP, Flamm SD, Antonopoulos AS, Shirodaria C, Sabharwal N, Deanfield J, Neubauer S, Hopewell JC, Channon KM, Achenbach S, Antoniades C. Non-invasive detection of coronary inflammation using computed tomography and prediction of residual cardiovascular risk (the CRISP CT study): a post-hoc analysis of prospective outcome data. Lancet. 2018 Sep 15;392(10151):929-939. doi: 10.1016/S0140-6736(18)31114-0. Epub 2018 Aug 28.
PubMed 30170852
Hoshino M, Yang S, Sugiyama T, Zhang J, Kanaji Y, Yamaguchi M, Hada M, Sumino Y, Horie T, Nogami K, Ueno H, Misawa T, Usui E, Murai T, Lee T, Yonetsu T, Kakuta T. Peri-coronary inflammation is associated with findings on coronary computed tomography angiography and fractional flow reserve. J Cardiovasc Comput Tomogr. 2020 Nov-Dec;14(6):483-489. doi: 10.1016/j.jcct.2020.02.002. Epub 2020 Feb 6.
PubMed 32057707
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

Want to know more?

Bon-Kwon Koo, MD, PhD

+82-1033561869

bkkoo@snu.ac.kr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Stenosis and Plaque Features in Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes After Invasive Coronary Angiography
ClinicalTrials.gov ID: NCT04547231
Acronym / sponsor ID: PRIME-CT / H-2007-201-1144
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease, Coronary CT angiography, Atherosclerosis, Fractional Flow Reserve, Clinical outcome, Pharmacotherapy, Percutaneous coronary intervention
Study type: Observational
Recruitment status: Unknown status
Enrolment: 992 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Seoul National University Bundang Hospital, Keimyung University Dongsan Medical Center, Ulsan Hospital, Inje University, Sejong General Hospital, Chosun University Hospital, Gachon University Gil Medical Center, Dong-A University Hospital, Wonju Severance Christian Hospital, Incheon St.Mary's Hospital, Tsuchiura Kyodo General Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Dong-A ST Co., Ltd.
Study start: 12 Aug 2020 (actual)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 14 Sep 2020 (actual)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Deferral of PCI group	–	Diagnostic Test: Fractional flow reserve, Coronary CT angiographyPatients with a vessel determined to defer revascularization after FFR measurement who undergo CCTA within 90 days before FFR measurement will be included.
PCI group	–	Diagnostic Test: Fractional flow reserve, Coronary CT angiographyPatients 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.

Who may qualify

Ages: 20 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Patients with suspected coronary artery disease who underwent CCTA within 90 days before FFR measurement will be included. If the patients receive PCI after FFR measurement, those with available both preprocedural and postprocedural FFR measurement will be included.

Key inclusion criteria (7 listed)

Age ≥ 20 years
Patients who undergo CCTA within 90 days before FFR measurement by clinical needs
Patients with a vessel determined to defer revascularization after FFR measurement.
Age ≥ 20 years
Patients who undergo CCTA within 90 days before FFR measurement by clinical needs

Key exclusion criteria (15 listed)

Left ventricular ejection fraction < 35%
Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
Abnormal epicardial coronary flow (TIMI flow < 3)
Failed FFR measurement
Planned coronary artery bypass graft surgery after diagnostic angiography

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
Fractional flow reserve, Coronary CT angiography1. 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).	Diagnostic test	Deferral of PCI group, PCI group

Primary outcome

Adverse cardiovascular event according to stenosis and plaque features (Deferral group).
Time frame: Upto 2 years after index procedure
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.
Adverse cardiovascular event according to pre-PCI FFR in vessels with low post-PCI FFR (PCI group).
Time frame: Upto 2 years after index procedure
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.

13 secondary outcomes

Additive prognostic value of stenosis and plaque features on CCTA over FFR in prediction of adverse cardiovascular events (Deferral group).
Time frame: Upto 2 years after index procedure
Comprehensive risk prediction model by integrating stenosis and plaque features, local hemodynamic parameters (Deferral group).
Time frame: Upto 2 years after index procedure
Clinical events and plaque and physiologic characteristics by medication history including antiplatelet agents and statin and serum lipid level during follow-up (Deferral group).
Time frame: Upto 2 years after index procedure
Prognostic value of CT-defined pericoronary and epicardial fat metrics (fat attenuation index [FAI], epicardial fat attenuation index [EFAI], and epicardial fat volume [EFV]) (Deferral group).
Time frame: Upto 2 years after index procedure
Risk prediction model by stenosis and plaque features, local hemodynamic parameters, and fat metrics and physiologic assessment (delta FFR and FFR) (Deferral group).
Time frame: Upto 2 years after index procedure
Risk of adverse cardiovascular events according to pre-PCI FFR (PCI group).
Time frame: Upto 2 years after index procedure
Prognostic impact of stenosis and plaque features on CCTA, local hemodynamic parameters (PCI group).
Time frame: Upto 2 years after index procedure
Comprehensive risk prediction model by integrating stenosis and plaque features on CCTA and physiologic assessment before and after PCI (PCI group).
Time frame: Upto 2 years after index procedure
Clinical events and plaque and physiologic characteristics by medication history including antiplatelet agents and statin and serum lipid level during follow-up (PCI group).
Time frame: Upto 2 years after index procedure
Prognostic value of CT-defined pericoronary and epicardial fat metrics (FAI, EFAI, EFV) (PCI group).
Time frame: Upto 2 years after index procedure
Risk prediction model by stenosis and plaque features, local hemodynamic parameters, and fat metrics and physiologic assessment (delta FFR and FFR) (PCI group).
Time frame: Upto 2 years after index procedure
Comparison of risk for future events by comprehensive CCTA analysis and physiologic assessment between the deferral of PCI and PCI group (Whole population).
Time frame: Upto 2 years after index procedure
Relationship among FFR values, CT-derived plaque qualification and quantification, and CT-defined pericoronary and epicardial fat metrics including FAI, EFAI, and EFV (Whole population).
Time frame: Upto 2 years after index procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
Background: PubMed 21247313Stone 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.
Background: PubMed 29020260Lee 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.
Background: PubMed 26205589Motoyama 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.
Background: PubMed 8637515Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
Background: PubMed 19144937Tonino 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.
Background: PubMed 29785878Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.
Background: PubMed 32227755Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
Background: PubMed 31097161Lee JM, Choi KH, Koo BK, Park J, Kim J, Hwang D, Rhee TM, Kim HY, Jung HW, Kim KJ, Yoshiaki K, Shin ES, Doh JH, Chang HJ, Cho YK, Yoon HJ, Nam CW, Hur SH, Wang J, Chen S, Kuramitsu S, Tanaka N, Matsuo H, Akasaka T. Prognostic Implications of Plaque Characteristics and Stenosis Severity in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2019 May 21;73(19):2413-2424. doi: 10.1016/j.jacc.2019.02.060.
Background: PubMed 29406855Driessen 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.
Background: PubMed 26763790Gaur S, Ovrehus KA, Dey D, Leipsic J, Botker HE, Jensen JM, Narula J, Ahmadi A, Achenbach S, Ko BS, Christiansen EH, Kaltoft AK, Berman DS, Bezerra H, Lassen JF, Norgaard BL. Coronary plaque quantification and fractional flow reserve by coronary computed tomography angiography identify ischaemia-causing lesions. Eur Heart J. 2016 Apr 14;37(15):1220-7. doi: 10.1093/eurheartj/ehv690. Epub 2016 Jan 12.
Background: PubMed 29311033Ahmadi A, Leipsic J, Ovrehus KA, Gaur S, Bagiella E, Ko B, Dey D, LaRocca G, Jensen JM, Botker HE, Achenbach S, De Bruyne B, Norgaard BL, Narula J. Lesion-Specific and Vessel-Related Determinants of Fractional Flow Reserve Beyond Coronary Artery Stenosis. JACC Cardiovasc Imaging. 2018 Apr;11(4):521-530. doi: 10.1016/j.jcmg.2017.11.020. Epub 2018 Jan 5.
Background: PubMed 32703590Hwang D, Lee JM, Yang S, Chang M, Zhang J, Choi KH, Kim CH, Nam CW, Shin ES, Kwak JJ, Doh JH, Hoshino M, Hamaya R, Kanaji Y, Murai T, Zhang JJ, Ye F, Li X, Ge Z, Chen SL, Kakuta T, Koo BK. Role of Post-Stent Physiological Assessment in a Risk Prediction Model After Coronary Stent Implantation. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1639-1650. doi: 10.1016/j.jcin.2020.04.041.
Individual participant dataSharing planned: Undecided. The sharing plan will be decided by the study committee

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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.

Bon-Kwon Koo, MD, PhD contact

+82-1033561869

bkkoo@snu.ac.kr

Seokhun Yang, MD contact

+82-1025953470

newturnz7@gmail.com

Bon-Kwon Koo, MD, PhD study chair

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 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 7 inclusion and 15 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 23 Mar 2021. 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?

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 (+82-1033561869, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse cardiovascular event according to stenosis and plaque features (Deferral group). (time frame: Upto 2 years after index procedure). The study lists 2 primary outcomes in all. 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 NCT04547231, which also lists 16 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 23 Mar 2021.