Evaluating plaque characteristics in patients with non-ST-segment acute coronary syndrome

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

This study is testing if using special imaging to look at heart plaque can help predict serious heart problems better in patients with non-ST-segment acute coronary syndrome.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Chest Hospital (Academic / other)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT03641898 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess whether adding intravascular ultrasound (IVUS) evaluation of plaque morphology to fractional flow reserve (FFR) assessment can improve the prediction of major adverse cardiovascular events (MACEs) in patients with non-ST-segment acute coronary syndrome (NSTEACS). The study will involve NSTEACS patients undergoing FFR for lesions with intermediate to severe stenosis, followed by FFR-guided percutaneous coronary intervention (PCI) and IVUS assessment of FFR-negative lesions. Patients will receive optimal medication treatment post-discharge and will be monitored for MACEs during follow-up. The study is conducted at a single center, Tianjin Chest Hospital.

Who should consider this trial

Good fit: Ideal candidates are moderate to high-risk NSTEACS patients requiring an invasive strategy and who can comply with the study protocol.

Not a fit: Patients with STEMI, severe hemodynamic instability, or contraindications for FFR, PCI, IVUS, or optimal medical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better risk stratification and management of patients with NSTEACS, potentially reducing the incidence of major adverse cardiovascular events.

How similar studies have performed: While the use of FFR and IVUS in coronary assessments has been explored, this specific combination in the context of NSTEACS is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin

• Tianjin Chest Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Jia Zhou, MD

Conditions Non-ST-segment Acute Coronary Syndrome; Fractional flow reserve; Intravascular ultrasound; Major adverse cardiovascular events; Non-ST-segment acute coronary syndrome; Percutaneous coronary intervention