Physiology & Optical Coherence in STEMI

Not Applicable

• Conditions: Myocardial Infarction
• Interventions: Procedure: function or imaging guided PCI

• Registration Number: NCT03992924
• Lead Sponsor: Shenyang Northern Hospital

Brief Summary

The objective of this study is to prospectively evaluate the outcomes of different treatment pathways using a Physiology \& Imaging guided PCI in patients with STMEI.

A multi-centre study that will prospectively enrol consecutive STEMI patients who don't receive primary PCI within 48 hours after symptom onset because of different reasons.

STEMI patients with culprit lesion stenosis between 0%-90% will be included in this study and randomized to angiography-guided, FFR-guided or OCT guided PCI groups.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Study First Posted: 2019-06-20
• Last Update Posted: 2019-06-20
• Study Start: 2019-10
• Primary Completion: 2021-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age ≥18 years STEMI for 7-30 days Have not undergone PCI because: Stabilization in a non-PCI hospital followed by transfer to a tertiary hospital for further evaluation;Previous emergent angio without ballooning or stenting;Previous emergent Thrombus Aspiration without ballooning or stenting;Pharmacoinvasive therapy Stenosis between 0%-90% TIMI flow grad 3

Exclusion Criteria

• Left main disease or bypass disease Intolerance to a study drug, metal alloys, or contrast media Life expectancy less than one year Previous PCI or CABG history Cardiogenic shock or LVEF<35% Severe renal or hepatic dysfunction, hemodynamic instability >90% stenosis in culprit lesion TIMI flow ≤ grade 2 Planned surgery within 6 months after index procedure Clinical indications of inability to tolerate DAPT for 12 months Inability to provide written informed consent Participation in another trial before reaching the primary endpoint

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFR-guided PCI	function or imaging guided PCI	-
angiography-guided PCI	function or imaging guided PCI	-
OCT-guided PCI	function or imaging guided PCI	-

Primary Outcome Measures

Name	Time	Method
One-year target lesion failure (TLF)	12 month	a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR).

Secondary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Cardiovascular Events (MACE)	12 month	Death from cardiac causes, ARC defined Stent Thrombosis, Non-fatal MI, Clinically driven target vessel revascularization (TVR) or re-hospitalization due to unstable or progressive angina

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China