Physiology & Optical Coherence in STEMI

NCT03992924 — Not applicable, Unknown, 300 participants, Shenyang Northern Hospital

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A Prospective Evaluation of Clinical Impact of Physiology & Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI

Registry	NCT03992924
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	300 (Estimated)
Sponsor	Shenyang Northern Hospital (Other)
Conditions	Myocardial Infarction
Interventions	function or imaging guided PCI (Procedure)
Dates	start 2019-10-01 (estimated), primary completion 2021-10-01 (estimated), completion 2022-10-01 (estimated), first posted 2019-06-20, last updated 2019-06-20
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions
angiography-guided PCI	Active comparator	Procedure: function or imaging guided PCI
FFR-guided PCI	Experimental	Procedure: function or imaging guided PCI
OCT-guided PCI	Experimental	Procedure: function or imaging guided PCI

function or imaging guided PCI (Procedure): FFR may be good tools to differentiate patients with STEMI who may not need stent implantation from those who need Optical coherence tomography (OCT) can visualize the microstructure of culprit and the OCT characteristics were validated by histology

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
General Hospital of Northern Theater Command	Shenyang	China

My Notes

Public

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