Verona Coronary Physiology Interventional Registry
- Conditions
- Coronary Artery DiseaseIschemic Heart Disease (IHD)Coronary Heart Disease (CHD)
- Registration Number
- NCT07186582
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vessel-Oriented Composite Endpoint (VOCE) 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.
- Secondary Outcome Measures
Name Time Method Cardiovascular death At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography Deaths attributed to cardiovascular causes, adjudicated according to ARC-2 definitions.
Target vessel-related myocardial infarction At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography Myocardial infarction classified as related to the target vessel, defined by the 4th Universal Definition of MI.
Target vessel revascularization At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography Any ischemia-driven percutaneous or surgical revascularization of the target vessel, based on symptoms, ischemia testing, or invasive physiology criteria.
Hospitalization for unstable angina At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography Number and timing of hospital admissions due to unstable angina.
Angina status (Seattle Angina Questionnaire) At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography Assessment of angina symptoms and quality of life using the validated Seattle Angina Questionnaire.
Number of prescribed antianginal medications At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography Count of antianginal drugs prescribed to each patient during the follow-up period.
Trial Locations
- Locations (1)
Azienda Ospedaliera Universitaria Integrata Verona(AOUI)
🇮🇹Verona, VR, Italy
Azienda Ospedaliera Universitaria Integrata Verona(AOUI)🇮🇹Verona, VR, Italy