Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography
ACCURATE
Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
1 other identifier
observational
318
1 country
1
Brief Summary
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2020
CompletedFirst Submitted
Initial submission to the registry
December 6, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2022
CompletedMarch 8, 2023
December 1, 2022
8 months
December 6, 2020
March 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
Hemodynamically significant coronary artery stenosis: FFR≤0.8
7 days
Secondary Outcomes (2)
Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
7 days
AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis
7 days
Interventions
FFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images
Eligibility Criteria
Patients with stable angina, unstable angina or myocardial infarction after the acute phase
You may qualify if:
- Age ≥18 years;
- Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
- Able to provide informed consent.
You may not qualify if:
- Subjects judged unsuitable for diagnostic intervention or FFR;
- Myocardial infarction within 6 days;
- LVEF ≤50%;
- eGFR \<60ml/min（1.73m²）
- Severe coagulation dysfunction or bleeding disorders;
- Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;
- Participated in other clinical trials within 1 months;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310009, China
Related Publications (1)
Jiang J, Hu Y, Li C, Dong L, Xu J, Tang L, Jiang W, Du C, Jiang X, Lyu Y, Leng X, Li C, Koo BK, Xiang J, Ge J, Wang J. Diagnostic Accuracy of Computational Fluid Dynamics-Based Fractional Flow Reserve Derived From Coronary Angiography: The ACCURATE Study. J Am Heart Assoc. 2025 Jan 7;14(1):e035672. doi: 10.1161/JAHA.124.035672. Epub 2024 Dec 24.
PMID: 39719423DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2020
First Posted
March 24, 2021
Study Start
November 4, 2020
Primary Completion
June 28, 2021
Study Completion
February 24, 2022
Last Updated
March 8, 2023
Record last verified: 2022-12