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

August 19, 2019 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

Unknown

Conditions

Intervention / Treatment

Detailed Description

Based on the clinical fact that less stress single photon emission computed tomography (SPECT) and stress magnetic resonance imaging (MRI) 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 registry is aim 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

Interventional

Enrollment (Anticipated)

1216

Phase

  • 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 Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Junjie Yang, MD
        • Contact:
          • Dongkai Shan, MD

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

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New or worsening chest pain suspicious for clinically significant coronary artery disease
  • Coronary CTA result showed that the diameter stenosis is more than 30% in one major coronary artery at least (coronary artery diameter greater than 2.5mm)
  • Intermediate likelihood 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 urgent or emergent testing
  • Hemodynamically or clinically unstable condition systolic blood pressure < 90 mmHg or serious atrial or ventricular arrhythmias
  • Persistent resting chest pain felt to be ischemic despite adequate therapy
  • 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
  • Any invasive or non-invasive anatomic or functional cardiovascular test for detection of CAD, including ICA and exercise ECG within the previous 12 months
  • Known significant congenital, valvular (moderate and above) or cardiomyopathy process (hypertrophic cardiomyopathy or reduced systolic left ventricular function ≤ 40%) which could explain cardiac symptoms
  • Contraindication to undergo coronary CTA, including but not limited to allergy to iodinated contrast agent, unable to receive β-blockers if needed during CT procedural, pregnancy, serum creatinine ≥1.5 mg/dL
  • 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
Intervention / Treatment
Experimental: CTA/CT-FFR care group
If the subjects are randomly allocated to CTA/CT-FFR arm, they will be examined by DeepFFR for three major epicardial arteries. If CT-FFR value of one or more major coronary arteries is less than 0.75, ICA will be performed directly; if CT-FFR is 0.75-0.8 (including 0.8), physicians will decide whether to start intensive drug therapy or ICA; if CT-FFR value is more than 0.8, only drug therapy will be needed. The clinical management plan will be suggested including optimal medical therapy, ICA, PCI, CABG and other intervention according to the result of this non-invasive examination.
Diagnostic test: CT-FFR
When subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DeepFFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values in artificial intelligence model.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 DeepFFR, 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 2-3cm downstream of an interest lesion.
No Intervention: routine clinically-indicated diagnostic care group
If the subjects are randomized to CID arm, attending physicians will decide next step of diagnosis and treatment, such as exercise ECG, stress cardiac echo, 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

Outcome Measure
Measure Description
Time Frame
Rate of ICA without obstructive CAD or intervention
Time Frame: 90 days
Percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis≥50% 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

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular event
Time Frame: 90 days，6 months，12 months
Major adverse cardiovascular event include death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization
90 days，6 months，12 months
Medical expenditure
Time Frame: 90 days，12 months
Medical expenditure by intention to treat at both 90 days and 12 months cumulatively
90 days，12 months
Quality of life score
Time Frame: 12 months
Quality of life score evaluated as quality of life (QOL), which is measured by Seattle Angina Questionnaire Scale, used 11-item instrument that measures patient reported symptoms, function and QOL for subjects with CAD within 12 months
12 months
Cumulative radiation exposure
Time Frame: 90 days, 12 months
Cumulative radiation exposure for any examination within 90 days and 12 months
90 days, 12 months

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

Collaborators

Tongji Hospital
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Xinjiang Medical University
Anzhen Hospital, Capital Medical University, Beijing

Investigators

  • 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)

May 10, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 30, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Coronary Artery Disease

Clinical Trials on CT-FFR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe