Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE (ADVANCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,737
- 主要终点
- Percentage of Participants With Reclassification of CAD Management, Assessed as the Therapeutic Recommendations Made Based on Review of Coronary CTA Alone Versus CTA + FFRCT, When Available, by a Central Integration Core Laboratory.
研究概览
简要总结
The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (CAD) in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.
详细描述
REGISTRY OBJECTIVE
The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.
SPECIFIC OBJECTIVES:
- To determine if the availability of FFRCT, in addition to coronary anatomy from the cCTA, will lead to a significant change in the coronary management plan.
- To assess the real world outcomes of utilizing FFRCT to guide invasive management and/or medical treatment.
- To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test.
- To provide society including patients, health care providers, and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.
排除标准
- •cCTA showing no CAD
- •Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation
- •Any active, serious, life-threatening disease with a life expectancy of less than 1 year
- •Inability to comply with follow-up requirements
结局指标
主要结局
Percentage of Participants With Reclassification of CAD Management, Assessed as the Therapeutic Recommendations Made Based on Review of Coronary CTA Alone Versus CTA + FFRCT, When Available, by a Central Integration Core Laboratory.
时间窗: at 90 days
The reclassification rate of management plans was assessed by the blinded independent review committee and local physician teams separately. These evaluations are meant to assess the potential impact of FFRCT on downstream testing and clinical decision making but were not be used to determine actual patient care. This endpoint is aimed at determining the incremental value of FFRCT over coronary CTA alone in the management of stable angina. FFRCT is non-invasive method to determine FFR which computes the hemodynamic significance of CAD (FFRCT) from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions (Taylor 2013).
次要结局
- Percentage of Participants With Invasive Catheterization Without Obstructive Disease(At 90 days)
- Percentage of Individual Components of MACE at 90 Days(90 days)
- Percentage of Major Adverse Coronary Events (MACE) at 1 Year(1 year)
- Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management(at 90 days)
- Percentage of Major Adverse Coronary Events (MACE) at 90 Days(90 days)
- Cumulative Radiation Exposure From cCTA MilliSievert (mSv)(Baseline)
- Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan(90 days)
- Percentage of Individual Components of MACE at 1 Year(1 year)