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

NCT04547231 | Unknown DMC

• 1 other identifier: H-2007-201-1144
• Study Type: observational
• Target: 992
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Coronary CT angiography; Atherosclerosis; Fractional Flow Reserve; Clinical outcome; Pharmacotherapy; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Additive prognostic value of stenosis and plaque features on CCTA over FFR in prediction of adverse cardiovascular events (Deferral group).

  Upto 2 years after index procedure

• Comprehensive risk prediction model by integrating stenosis and plaque features, local hemodynamic parameters (Deferral group).

  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).

  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).

  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).

  Upto 2 years after index procedure

Study Arms (2)

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.

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.

Diagnostic Test: Fractional flow reserve, Coronary CT angiography

Interventions

Fractional flow reserve, Coronary CT angiography DIAGNOSTIC_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).

Deferral of PCI group; PCI group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• \) PCI group
• 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).
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Ulsan Hospital: collaborator
• Inje University: collaborator
• Sejong General Hospital: collaborator
• Chosun University Hospital: collaborator
• Gachon University Gil Medical Center: collaborator
• Dong-A University Hospital: collaborator
• Wonju Severance Christian Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator
• Tsuchiura Kyodo General Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Dong-A ST Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Select, 03080, South Korea

RECRUITING

Related Publications (16)

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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 CHAIR

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

+82-1033561869; bkkoo@snu.ac.kr

Seokhun Yang, MD

CONTACT

+82-1025953470; newturnz7@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: August 12, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

KR (1)