Intravascular Ultrasound-derived Assessment of Hemodynamically Negative Lesions in NSTEACS Patients

Non-ST-segment Acute Coronary Syndrome Clinical Trial

— IMPACT-NSTEACS  

Official title:

Intravascular Ultrasound-derived Morphometric Assessment of Fractional Flow Reserve Negative Lesions to Predict Cardiovascular Outcomes in Non-ST-segment Acute Coronary Syndrome Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641898
• Other study ID #: 16KG132
• Status: Recruiting
• Start date: October 20, 2018
• Est. completion date: October 2025

Study information

• Verified date: July 2019
• Source: Tianjin Chest Hospital
• Contact: Jia Zhou, MD
• Phone: 86-15522485560
• Email: zhoujiawenzhang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2025
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Clinical Inclusion Criteria:

1. Moderate to high risk NSTEACS requiring invasive strategy based on current guidelines and local clinical practice.

2. Patient agrees and is able to follow all protocol procedures.

Clinical Exclusion Criteria:

1. STEMI or SCAD.

2. Hemodynamic instability (e.g. cardiogenic shock, refractory ventricular arrhythmias, acute and severe conduction system disease and left ventricular ejection fraction =30%).

3. 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).

4. PCI within 6 months or any prior CABG.

5. Anticipated life expectancy <3 year.

6. Pregnancy

7. Unwilling or unable to provide informed consent

Imaging Inclusion Criteria

1. 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 %.

2. 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.

3. The FFR-negative lesions must be available for assessment of IVUS.

Imaging Exclusion Criteria:

1. Target lesion reference diameter <2.0 mm.

2. Anatomic conditions precluding FFR and IVUS (e.g. marked calcification or tortuosity, chronic total occlusion or thrombus).

3. After successful FFR-guided PCI, no FNL is left.

4. Any remaining lesion with diameter stenosis =90% or FFR<0.8 after PCI.

5. Left main coronary artery lesion.

6. CABG planned by the investigators according to extent and severity of coronary artery disease.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Non-ST-segment Acute Coronary Syndrome
• Syndrome

Intervention

Procedure:
• FFR-guided PCI
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.

Diagnostic Test:
• Intravascular ultrasound
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.

Locations

Country	Name	City	State
China	Tianjin Chest Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	5 years
Other	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	5 years
Primary	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	3 years
Secondary	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	3 years