Role of On-site CT-derived FFR in the Management of Suspect CAD Patients (TARGET)
Coronary Artery Disease
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
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
Experimental
No Intervention
CTA/CT-FFR care group
routine clinically-indicated diagnostic 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.
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.