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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-ST-segment Acute Coronary Syndrome
• Intervention / Treatment: Procedure: FFR-guided PCI; Diagnostic test: Intravascular ultrasound

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.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Jia Zhou, MD; Phone Number: 86-15522485560; Email: zhoujiawenzhang@126.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin Chest Hospital
      • Contact: Jia Zhou, MD; Phone Number: 86-15522485560; Email: zhoujiawenzhang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Morphometric assessment of FNLs; After FFR-guided PCI, the morphometric characteristics of FNLs (FFR>0.8) are assessment by intravascular ultrasound.

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.; Other Names: Functionally complete revascularization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tianjin Chest Hospital
• Investigators: Study Chair: Ying Zhang, MD, Tianjin Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2018
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: August 18, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Fractional flow reserve; Percutaneous coronary intervention; Intravascular ultrasound; Major adverse cardiovascular events; Non-ST-segment acute coronary syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 16KG132

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No