Impact of Coronary CT Angiography, Physiologic Assessment and Pharmacotherapy on the Clinical Outcomes (PRIME-CT)

March 19, 2021 updated by: Bon-Kwon Koo, Seoul National University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
992

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Select
      • Seoul, Select, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
  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.
Diagnostic test: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Upto 2 years after index procedure
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.
Upto 2 years after index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Comparison of outcome discrimination ability.
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
Risk prediction model using conventional statistics or machine learning.
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
Changes in lesion characteristics and outcome by medication history.
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
Prognostic implications of fat metrics.
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 prediction model using conventional statistics or machine learning.
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 implications of pre-PCI FFR after PCI.
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
Prognostic implications of stenosis and plaque features on CCTA after PCI.
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
Risk prediction model using conventional statistics or machine learning.
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
Changes in lesion characteristics and outcome by medication history.
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
Prognostic implications of fat metrics.
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
Risk prediction model using conventional statistics or machine learning.
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
Risk comparison and prediction model using conventional statistics or machine learning.
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
Association among CCTA parameters and physiologic indices.
Upto 2 years after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seoul National University Bundang Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Gachon University Gil Medical Center
Inje University
Dong-A ST Co., Ltd.
Keimyung University Dongsan Medical Center
Dong-A University Hospital
Wonju Severance Christian Hospital
Incheon St.Mary's Hospital
Chosun University Hospital
Tsuchiura Kyodo General Hospital
Ulsan Hospital
Sejong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-2007-201-1144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sharing plan will be decided by the study committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Fractional flow reserve, Coronary CT angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings