Clinical trial NCT03901326: Role of On-site CT-derived FFR in the Management of Suspect CAD Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Coronary computed tomographic angiography
Fractional flow reserve
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Qilu Hospital of Shandong University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Tongji Hospital
First posted: 2019-04-03
Enrollment: 1216
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With ICA Without Obstructive CAD or Intervention
timeFrame: 90 days
Secondary outcomes:
measure: Number of Participant With Major Adverse Cardiovascular Event
timeFrame: 12 months
measure: Medical Expenditure
timeFrame: 12 months
measure: Patient Reporting Outcomes
timeFrame: Study entry, 3 months, 6 months and12 months
measure: Cumulative Radiation Exposure
timeFrame: 90 days, 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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