Coronary Artery Disease, ST Elevation Myocardial Infarction
Conditions
Brief summary
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).
Interventions
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.
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.
Sponsors
Wuhan Asia Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vessel-oriented composite endpoints (VOCEs) | 1 year | Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. |
| Post-PCI AccuFFRangio | 1 year | AccuFFRangio limits to yield no VOCEs (Composite of vessel-related cardiovascular death, vessel-related myocardial). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost analysis | 1 year | Cost savings of AccuFFRangio-guided strategy. Evaluation of costs by excess/reduced need for PCI when AccuFFRangio and Angiography disagree. |
| Prognostic implications | 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. |
Contacts
Primary ContactDan Song, MD
Outcome results
None listed