Coronary Artery Disease Clinical Trial
— PRIME-CTOfficial title:
Impact of Stenosis and Plaque Features in Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes After Invasive Coronary Angiography
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.
Status | Recruiting |
Enrollment | 992 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 20 Years and older |
Eligibility | 1) Deferral of PCI group Inclusion Criteria: 1. Age = 20 years 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. Exclusion Criteria: 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 2) PCI group Inclusion Criteria: 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). - Patients with multiple vessels that meet inclusion criteria of the deferral of PCI group and PCI group will be assigned to the PCI group. Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Select |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Chosun University Hospital, Dong-A ST Co., Ltd., Dong-A University Hospital, Gachon University Gil Medical Center, Incheon St.Mary's Hospital, Inje University, Keimyung University Dongsan Medical Center, Sejong Hospital, Seoul National University Bundang Hospital, The Second Affiliated Hospital Zhejiang University, Tsuchiura Kyodo General Hospital, Ulsan Hospital, Wonju Severance Christian Hospital |
Korea, Republic of,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Upto 2 years after index procedure | |
Primary | 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. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | Comprehensive risk prediction model by integrating stenosis and plaque features, local hemodynamic parameters (Deferral group). | Risk prediction model using conventional statistics or machine learning. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | Risk of adverse cardiovascular events according to pre-PCI FFR (PCI group). | Prognostic implications of pre-PCI FFR after PCI. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | Prognostic value of CT-defined pericoronary and epicardial fat metrics (FAI, EFAI, EFV) (PCI group). | Prognostic implications of fat metrics. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure | |
Secondary | 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. | Upto 2 years after index procedure |
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