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

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Diagnostic Test: CT-FFR assessment

Registration Number: NCT03901326

Lead Sponsor: Chinese PLA General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1216

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTA/CT-FFR care group	CT-FFR assessment	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With ICA Without Obstructive CAD or Intervention	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participant With Major Adverse Cardiovascular Event	12 months	Major adverse cardiovascular event include death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization
Medical Expenditure	12 months	Overall cardiac medical expenditure by intention to treat at both 90 days and 12 months cumulatively
Cumulative Radiation Exposure	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
Patient Reporting Outcomes	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.