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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CT-FFR

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Coronary computed tomographic angiography, Fractional flow reserve

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CTA/CT-FFR care group

routine clinically-indicated diagnostic care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of ICA without obstructive CAD or intervention

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.

Secondary Outcome Measures

Major adverse cardiovascular event

Major adverse cardiovascular event include death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization

Medical expenditure

Medical expenditure by intention to treat at both 90 days and 12 months cumulatively

Quality of life score

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

Cumulative radiation exposure

Cumulative radiation exposure for any examination within 90 days and 12 months

Full Information

NCT ID

NCT03901326

First Posted

March 30, 2019

Last Updated

August 19, 2019

Sponsor

Chinese PLA General Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03901326

Brief Title

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

Acronym

TARGET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary artery disease, Coronary computed tomographic angiography, Fractional flow reserve

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CTA/CT-FFR care group

Arm Type

Experimental

Arm Description

Arm Title

routine clinically-indicated diagnostic care group

Arm Type

No Intervention

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

CT-FFR

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of ICA without obstructive CAD or intervention

Description

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Major adverse cardiovascular event

Description

Major adverse cardiovascular event include death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization

Time Frame

90 days，6 months，12 months

Title

Medical expenditure

Description

Medical expenditure by intention to treat at both 90 days and 12 months cumulatively

Time Frame

90 days，12 months

Title

Quality of life score

Description

Time Frame

12 months

Title

Cumulative radiation exposure

Description

Cumulative radiation exposure for any examination within 90 days and 12 months

Time Frame

90 days, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junjie Yang, MD

Phone

86-13581662680

Fearlessyang@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dongkai Shan, MD

Phone

86-15910616698

shandongkai1234@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yundai Chen, Ph.D.

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junjie Yang, MD

First Name & Middle Initial & Last Name & Degree

Dongkai Shan, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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