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NCT Number: NCT07186582

Verona Coronary Physiology Interventional Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Heart Disease (CHD) Heart Diseases Ischemic Heart Disease (IHD) Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Integrata Verona(AOUI)

Verona, VR, 37126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFR

Diagnostic Test

Functional assessment of coronary lesions performed using invasive FFR or angiography-derived FFR during coronary angiography as part of routine clinical care. No active intervention or treatment is assigned by the study.

Primary outcomes

  1. Vessel-Oriented Composite Endpoint (VOCE)

    Time frame: 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 outcomes

  1. Cardiovascular death

    Time frame: 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.

  2. Target vessel-related myocardial infarction

    Time frame: 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.

  3. Target vessel revascularization

    Time frame: 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.

  4. Hospitalization for unstable angina

    Time frame: 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.

  5. Angina status (Seattle Angina Questionnaire)

    Time frame: 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.

  6. Number of prescribed antianginal medications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Acronym: VR-CP

Important dates

Study start
2025
Primary completion
2025
Study completion
2034
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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