Back to resultsPhysiology & Optical Coherence in STEMI
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
function or imaging guided PCI
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
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
Sites / Locations
- General Hospital of Northern Theater Command
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
angiography-guided PCI
FFR-guided PCI
OCT-guided PCI
Arm Description
Outcomes
Primary Outcome Measures
One-year target lesion failure (TLF)
a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR).
Secondary Outcome Measures
Incidence of Major Adverse Cardiovascular Events (MACE)
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
Full Information
NCT ID
NCT03992924
First Posted
June 19, 2019
Last Updated
June 19, 2019
Sponsor
Shenyang Northern Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03992924
Brief Title
Physiology & Optical Coherence in STEMI
Official Title
A Prospective Evaluation of Clinical Impact of Physiology & Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
angiography-guided PCI
Arm Type
Active Comparator
Arm Title
FFR-guided PCI
Arm Type
Experimental
Arm Title
OCT-guided PCI
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
function or imaging guided PCI
Intervention Description
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
Primary Outcome Measure Information:
Title
One-year target lesion failure (TLF)
Description
a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR).
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Incidence of Major Adverse Cardiovascular Events (MACE)
Description
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
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Xu
Phone
+86-24-28897309
Email
xukai2001@sina.com
12. IPD Sharing Statement
Learn more about this trial
Physiology & Optical Coherence in STEMI
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