Verona Coronary Physiology Interventional Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Vessel-Oriented Composite Endpoint (VOCE)
研究概览
简要总结
The Verona Coronary Physiology Interventional Registry (VR-CP) is an observational study that collects information on patients with suspected coronary artery disease who underwent coronary angiography with a functional assessment of coronary stenoses. These functional tests include fractional flow reserve (FFR) or angiography-derived FFR, which help physicians understand whether a narrowing in the coronary arteries is likely to reduce blood flow to the heart.
The main goal of the study is to investigate whether the functional severity of coronary lesions is associated with future cardiovascular events, such as heart attack, the need for repeat procedures, or cardiovascular death. Additional objectives are to compare invasive FFR with angiography-derived FFR, to evaluate how these values relate to angina symptoms, and to analyze differences between patients treated conservatively with medications and those treated with coronary interventions.
The study is retrospective and single-center, including approximately 1,000 patients who underwent coronary physiology testing between 2010 and 2024 at the University Hospital of Verona. Follow-up information is obtained through review of medical records, outpatient visits, or telephone contacts, and patients will be followed for up to 10 years.
By combining detailed coronary physiology data with long-term clinical outcomes, this registry aims to improve understanding of which patients are at higher risk and to guide future strategies for the diagnosis and treatment of coronary artery disease.
详细描述
Coronary artery disease (CAD) remains one of the leading causes of morbidity and mortality worldwide. Conventional coronary angiography is limited because it shows the anatomy of the vessels but does not always reveal whether a narrowing truly reduces blood flow. To address this limitation, physiological indices such as fractional flow reserve (FFR) and angiography-derived FFR have been developed to provide a more accurate assessment of the functional severity of coronary stenoses.
The VR-CP registry is designed to evaluate the long-term prognostic value of these functional measurements. Patients who underwent coronary angiography with physiology testing at the University Hospital of Verona are included, and their angiographic data are linked to subsequent clinical outcomes. Follow-up information is collected through hospital records, outpatient visits, and telephone contacts, with a focus on major cardiovascular events and patient-reported angina status.
This study provides a unique opportunity to analyze a large, consecutive cohort over a long observation period. By correlating physiological lesion characteristics with outcomes such as myocardial infarction, target vessel revascularization, cardiovascular death, and quality-of-life measures, the registry aims to identify high-risk patient subgroups and refine treatment strategies.
The knowledge gained from this registry may contribute to more personalized decision-making in patients with CAD, improve the use of physiology in daily practice, and ultimately guide strategies for balancing conservative management versus invasive revascularization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Undergoing coronary angiography with functional assessment by FFR or angiography-derived FFR (index procedure)
- •Willing and able to provide informed, written consent
- •Age ≥ 18 years at the time of the index procedure
- •Exclusion Criteria
- •Impossibility to obtain informed consent
- •Age < 18 years at the time of the index procedure
排除标准
- 未提供
结局指标
主要结局
Vessel-Oriented Composite Endpoint (VOCE)
时间窗: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization as adjudicated by an independent Clinical Events Committee (CEC) blinded to patient clinical data.
次要结局
- Cardiovascular death(At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography)
- Target vessel-related myocardial infarction(At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography)
- Target vessel revascularization(At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography)
- Hospitalization for unstable angina(At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography)
- Angina status (Seattle Angina Questionnaire)(At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography)
- Number of prescribed antianginal medications(At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography)
研究者
Roberto Scarsini
MD, PhD
Azienda Ospedaliera Universitaria Integrata Verona