Physiology & Optical Coherence in STEMI

NCT03992924 | Unknown

• 1 other identifier: FFR-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• One-year target lesion failure (TLF)

  a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR).

  12 month

Secondary Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  12 month

Study Arms (3)

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

Interventions

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

FFR-guided PCI; OCT-guided PCI; angiography-guided PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, China

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Functional Status

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of cardiology

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 20, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

CN (1)