- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992924
Physiology & Optical Coherence in STEMI
A Prospective Evaluation of Clinical Impact of Physiology & Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Shenyang, China
- General Hospital of Northern Theater Command
-
Contact:
- Kai Xu
- Phone Number: +86-24-28897309
- Email: xukai2001@sina.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: angiography-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
|
Experimental: FFR-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
|
Experimental: OCT-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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
One-year target lesion failure (TLF)
Time Frame: 12 month
|
a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR).
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Major Adverse Cardiovascular Events (MACE)
Time Frame: 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
|
12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FFR-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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