Prognostic Implications of AccuFFRangio-guided PCI in STEMI
February 8, 2022 updated by: Wuhan Asia Heart Hospital
Prognostic Implications of AccuFFRangio-based Functional Evaluation for Guiding Coronary Intervention for Non-IRA Stenosis in Patients With STEMI
This is a prospective, single-center clinical trial.
AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images.
The aim of this study was to evaluate the diagnostic accuracy and prognostic implications of AccuFFRangio in patients with ST-segment elevation myocardial infarction (STEMI).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 Years and older
- STEMI patients with primary percutaneous coronary intervention within 24 hours with at least 1 non-IRA
- Diameter stenosis of 50%-90% by visual estimate
- Reference vessel size > 2 mm in stenotic segment by visual estimate
Exclusion Criteria:
- LVEF ≤ 40%
- eGFR < 60 mL/min
- Allergy to contrast media, adenosine
- Prior CABG
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AccuFFRangio Group
STEMI patients with multiple lesions who met the requirements of the study were enrolled and received coronary angiography.
First, the revascularization of the criminal vessel (PCI) was completed.
The patients were randomly grouped and divided into AccuFFRangio Group and Angiography Group if the treatment results were good.
The AccuFFRangio Group was defined as non-IRA of these patients who were treated with PCI after angio-FFR measurement with FFR≤0.8.
|
In this study, the AccuFFRangio-guided strategy will be applied to in the AccuFFRangio group in which calculation of the AccuFFRangio values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to PCI revascularization will be carried out.
If AccuFFRangio ≤ 0.80, then simultaneous PCI revascularization of target blood vessels will be carried out.
If AccuFFRangio > 0.80, then no PCI revascularization of target blood vessels will be carried out.
|
|
Active Comparator: Angiography Group
The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis > 70% based on angiographic results.
|
In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 70% (visual estimation) and suited for PCI revascularization will undergo PCI revascularization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vessel-oriented composite endpoints (VOCEs)
Time Frame: 1 year
|
Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
|
1 year
|
|
Post-PCI AccuFFRangio
Time Frame: 1 year
|
AccuFFRangio limits to yield no VOCEs (Composite of vessel-related cardiovascular death, vessel-related myocardial).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost analysis
Time Frame: 1 year
|
Cost savings of AccuFFRangio-guided strategy.
Evaluation of costs by excess/reduced need for PCI when AccuFFRangio and Angiography disagree.
|
1 year
|
|
Prognostic implications
Time Frame: 1 year
|
The time from randomization to first occurrence of any of composite outcome including vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 15, 2022
Primary Completion (Anticipated)
February 28, 2023
Study Completion (Anticipated)
May 31, 2023
Study Registration Dates
First Submitted
January 7, 2022
First Submitted That Met QC Criteria
January 21, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 8, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFCA20220105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.