Role of On-site CT-derived FFR in the Management of Suspect CAD Patients (TARGET)

December 11, 2023 updated by: Yundai Chen, Chinese PLA General Hospital

The Effect of On-site CT-derived Fractional Flow Reserve on the Management Making for the Patients With Stable Chest Pain (TARGET Trial)

The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce total medical expenditure. This registry is randomized, open labeled, prospective designed and will be performed in 6 Chinese hospitals. Approximately 1200 subjects will be enrolled and subsequently assigned to either routine clinically-indicated diagnostic care group (CID arm) or CTA/CT-FFR care group (CTA/CT-FFR arm) via computer-generated random numbers (1:1 ratio)

Study Overview

Status

Status

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

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

Based on the clinical fact that less stress myocardial perfusion scan are performed rather than stress exercise electrocardiogram (ECG) in China, more patients undergo coronary computed tomographic angiography (CTA) for determining whether they should be sent to catheter lab. However, nearly 30% of patients sent to catheter lab were found without obstructive coronary artery disease (CAD) and this invasive procedure was unnecessary and overused partly. Fortunately, fractional flow reserve (FFR) based non-invasive CT algorithm technology (CT-FFR) showed a great potential in detecting functional myocardial ischemia related to coronary specific lesion (Discovery-Flow, DEFACTO and NXT trial)[1-3]. Moreover, clinical care guided by CT-FFR could provide benefits with equivalent clinical outcomes and lower expenditure, compared with routine clinical care over 1-year follow-up (Platform trial). On the other aspect, ADVANCE trial revealed that CT-FFR modified treatment recommendation was associated with less negative invasive coronary angiography (ICA), predicted revascularization and identified subjects at low risk of adverse events through 90 days in real-world. However, these studies was not randomized designed and selection bias still existed. So our trial aims to evaluate whether CTA/CT-FFR outperforms the regular diagnostic care in ruling out patients without significantly obstructive CAD before catheter lab and improving clinical prognosis during follow-up in a randomized design.

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.
Interventional

Enrollment (Actual)

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.
1216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General 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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • New-onset chest pain suspicious for CAD
  • Coronary CTA result showed that the diameter stenosis is between 30 and 90% in at least one major coronary artery (coronary artery diameter ≥ 2.5 mm)
  • Intermediate-to-high pretest probability of CAD based on CAD Consortium Score
  • No prior evaluation for this episode of symptoms
  • Agree to participate in this clinical study and sign written informed consent

Exclusion Criteria:

  • Diagnosed or suspected acute coronary syndrome requiring hospitalization or emergent testing
  • Hemodynamically or clinically unstable condition systolic blood pressure < 90 mmHg or serious atrial or ventricular arrhythmias
  • Known CAD with prior myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or any angiographic evidence of ≥ 50% stenosis in any major coronary artery
  • Patients with left main branch stenosis ≥ 50% or major coronary artery stenosis > 90%
  • Known severe congenital, valvular (moderate and above), or cardiomyopathy process (hypertrophic cardiomyopathy or reduced systolic left ventricular function ≤ 40%) which could explain cardiac symptoms
  • Unable to provide written informed consent or participate in long-term follow-up.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: CTA/CT-FFR care group
If the subjects are randomly allocated to CT-FFR arm, they will be examined by on-site DeepFFR for three major epicardial coronary arteries. If the result of CT-FFR calculation is less than or equal to 0.8 in one or more major coronary arteries, the patient will be referred to ICA directly; if the result of CT-FFR value is more than 0.8, optimal medical therapy will be recommended. The decision on the mode of revascularization is left to the treating cardiologists and depends on local practice standard.
Diagnostic test: CT-FFR assessment
When subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DEEPVESSEL FFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values based on a machine learning algorithm. The first step is to extract a 3D coronary artery model and generate coronary centerlines which are similar to the routine reconstruction of coronary CTA. The centerlines are extracted using a minimal path extraction filter. Then a novel path-based deep learning model, referred to DEEPVESSEL FFR, is used to predict the simulated FFR values on the vascular centerlines. Deep learning algorithm is used to establish characteristic sample database of coronary hemodynamics characteristic parameters. When deep training model is proved to be valid, it is applied to a new lesion-specific measurement. Lesion-specific CT-FFR is defined as simulated FFR value at distance of 20mm away from the lesion of interest.
No Intervention: Routine clinically-indicated diagnostic care group
If the subjects are randomized to usual care arm, attending physicians will decide the next step of diagnosis and treatment, such as exercise ECG, stress cardiac echo, cardiac MR, and SPECT. According to the results of examination combined with risk factors assessment and clinical manifestations, physicians should provide recommendation whether the subjects would undergo ICA or not.

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
Number of Participants With ICA Without Obstructive CAD or Intervention
Time Frame: 90 days
Number of those patients with planned ICA in whom no significant obstructive CAD (no stenosis≥70% by core lab quantitative analysis or invasive FFR≤0.8) is found or interventions (including stent implantation, balloon dilation and bypass graft) are performed during ICA within 90 days.
90 days

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
Number of Participant With Major Adverse Cardiovascular Event
Time Frame: 12 months
Major adverse cardiovascular event include death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization
12 months
Medical Expenditure
Time Frame: 12 months
Overall cardiac medical expenditure by intention to treat at both 90 days and 12 months cumulatively
12 months
Patient Reporting Outcomes
Time Frame: Study entry, 3 months, 6 months and12 months
Patient reporting outcomes as measured by Seattle Angina Questionnaire-7(SAQ-7) Scale, use SAQ-7-item instrument that measures patient reported symptoms, function and quality of life for subjects with CAD within 12 months. The SAQ-7 score is calculated as the average of the physical limitation score, quality of life score and angina frequency score. The physical limitation score, quality of life score and angina frequency score range from 0 to 100 each. Therefore, the SAQ-7 score also ranges from 0 to 100.The higher the SAQ-7 socre, physical limitation score, quality of life score and angina frequency score are, the better the quality of life for patients with angina.
Study entry, 3 months, 6 months and12 months
Cumulative Radiation Exposure
Time Frame: 90 days, 12 months
Cumulative radiation exposure for any examination within 90 days and 12 months. Due to not enough data acquired, the investigators decided not to report at this time
90 days, 12 months

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.
Chinese PLA General 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.
Tongji Hospital
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Beijing Anzhen Hospital
First Affiliated Hospital of Xinjiang Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yundai Chen, Ph.D., Chinese PLA General 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.
May 10, 2019

Primary Completion (Actual)

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.
October 30, 2022

Study Completion (Actual)

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.
October 31, 2022

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).
March 30, 2019

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.
April 1, 2019

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.
April 3, 2019

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.
May 31, 2024

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.
December 11, 2023

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.
December 1, 2023

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.
  • S2019-025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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