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

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: CT-FFR assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT03901326

S2019-025-01

Details and patient eligibility

About

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)

Full 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.

Enrollment: 1,216 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,216 participants in 2 patient groups

CTA/CT-FFR care group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: CT-FFR assessment

Routine clinically-indicated diagnostic care group

No Intervention group

Description:

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.