Physiology & Optical Coherence in STEMI

NCT ID: NCT03992924

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-10-31

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

angiography-guided PCI

Group Type: ACTIVE_COMPARATOR

function or imaging guided PCI

Intervention Type: 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

FFR-guided PCI

Group Type: EXPERIMENTAL

function or imaging guided PCI

Intervention Type: 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

OCT-guided PCI

Group Type: EXPERIMENTAL

function or imaging guided PCI

Intervention Type: 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

Interventions

function or imaging guided PCI

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Yaling

director of department of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

Facility Contacts

Kai Xu

Role: primary

xukai2001@sina.com

+86-24-28897309

Other Identifiers

FFR-1

Identifier Type: -

Identifier Source: org_study_id