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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tianjin Chest Hospital
  Tianjin, Tianjin, China Recruiting

Study contacts

• Study coordinator: Jia Zhou, MD
• Email: zhoujiawenzhang@126.com
• Phone: 86-15522485560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.