An observational study in Non-ST-segment Acute Coronary Syndrome, sponsored by Tianjin Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Tianjin Chest Hospital · Observational
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.
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.
For study enrollment, we screen patients with NSTEACS combination of unstable angina and non-ST-segment elevation myocardial infarction according to current guidelines. Once all clinical inclusion criteria and no clinical exclusion criteria are met, patients must sign the informed consent and undergo invasive coronary angiography (ICA). During ICA patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients will be enrolled into the study once the IVUS measurement is delivered after successful FFR-guided PCI.
Clinical Inclusion Criteria:
Clinical Exclusion Criteria:
Imaging Inclusion Criteria
Imaging Exclusion Criteria:
After FFR-guided PCI, the morphometric characteristics of FNLs (FFR\>0.8) are assessment by intravascular ultrasound.
Procedure: FFR-guided PCI · Diagnostic Test: Intravascular ultrasound
After the angiographic screening for lesions with 40%-90% diameter stenosis, FFR will be performed according to standard protocol using the s5 console and PrimeWire Prestige PLUS coronary pressure wire (Volcano Corporation, San Diego, California). FFR is calculated as the ratio of mean distal intracoronary pressure measured by the pressure wire, and the mean arterial pressure measured through the coronary guiding catheter. An FFR ≤0.8 or \>90% diameter stenosis should result in a treatment decision for revascularization by PCI and lesions with FFR \>0.80 are defined as FNLs and should result in deferral of PCI.
Also known as: Functionally complete revascularization
After the successful FFR-guided PCI, IVUS will be performed in all FNLs with the ultrasound Imaging Catheter Atlantis™ SR Pro (40 MHz, mechanical-type transducer, 3.2 F, Boston Scientific Corporation, Natick, MA, USA). Quantitative analyses of grayscale IVUS include contouring external elastic membrane (EEM) and luminal borders and the measurement of EEM cross-sectional area (CSA), luminal CSA, plaque and media CSA, plaque burdenand remodeling index. Virtual assessment of plaque is performed with iMap software (QIvus 2.0; Medis Medical Imaging Systems, Leiden, The Netherlands). Plaque components are categorized as dense calcium, necrotic core, fibrofatty, and fibrous tissue and reported as absolute area and proportion of total plaque area.
The incidence and predictors of MACEs related to FNLs
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Time frame: 3 years
The incidence of MACEs related to PCI-treated lesions
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Time frame: 3 years
The incidence and predictors of MACEs related to FNLs
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Time frame: 5 years
The incidence of MACEs related to PCI-treated lesions
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Time frame: 5 years
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Tianjin Chest Hospital