Intravascular Ultrasound-derived Morphometric Assessment of Fractional Flow Reserve Negative Lesions to Predict Cardiovascular Outcomes in Non-ST-segment Acute Coronary Syndrome Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-ST-segment Acute Coronary Syndrome
- Sponsor
- Tianjin Chest Hospital
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- The incidence and predictors of MACEs related to FNLs
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
This is an observational and prospective cohort study to examine whether the addition of IVUS plaque morphological evaluation to FFR haemodynamic assessment of non-culprit lesions in NSTEACS patients will better predict MACEs.
Detailed Description
IMPACT-NSTEACS is a prospective, single-centre and dynamic observational study. The study population consists of NSTEACS patients who undergo FFR in lesions with intermediate to severe angiographic stenosis. Then, FFR-guided PCI is performed, followed by morphological assessment based on IVUS in all FFR-negative lesions (FNLs). After discharge all patients receive optimal medication treatment and are followed up clinically. On the basis of follow-up angiography, MACEs are further adjudicated as occurring at FNLs or not.
Investigators
Ying Zhang
Senior Physician
Tianjin Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Moderate to high risk NSTEACS requiring invasive strategy based on current guidelines and local clinical practice.
- •Patient agrees and is able to follow all protocol procedures.
Exclusion Criteria
- •STEMI or SCAD.
- •Hemodynamic instability (e.g. cardiogenic shock, refractory ventricular arrhythmias, acute and severe conduction system disease and left ventricular ejection fraction ≤30%).
- •Contraindication for FFR, PCI, IVUS and OMT (e.g. severe allergy to antiplatelet drug or contrast, significant bleed within the past 6 months, bleeding diathesis and serum creatinine ≥2.5 mg/dl).
- •PCI within 6 months or any prior CABG.
- •Anticipated life expectancy \<3 year.
- •Unwilling or unable to provide informed consent
- •Imaging Inclusion Criteria
- •Patients must have at least \> 1 de novo lesion in a native coronary segment with a visually estimated diameter stenosis of between 40 and 90 %.
- •Successful FFR-guided PCI performed in all major epicardial coronary arteries (including their branches): PCI for all lesions a) with 40%-90% diameter stenosis and FFR\<0.8 and b) with ≥90% diameter stenosis.
- •The FFR-negative lesions must be available for assessment of IVUS.
Outcomes
Primary Outcomes
The incidence and predictors of MACEs related to FNLs
Time Frame: 3 years
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Secondary Outcomes
- The incidence of MACEs related to PCI-treated lesions(3 years)