Coronary Artery DiseaseVR-CPNCT07186582
Verona Coronary Physiology Interventional Registry
An observational study of Coronary Artery Disease and Ischemic Heart Disease (IHD), run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease (IHD), Coronary Heart Disease (CHD)
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2025to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who underwent coronary angiography for suspected coronary artery disease with functional assessment (coronary physiology) performed from 2010 to 2024.
Who may be able to join
- 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
Who cannot join
- Impossibility to obtain informed consent
- Age < 18 years at the time of the index procedure
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria Integrata Verona(AOUI)
Verona, VR, 37126
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFR
- Keywords
- Coronary Physiology, Fractional Flow Reserve (FFR), Radial Wall Strain, Intermediate Coronary Stenosis, Functional Coronary Angiography, Murray's law quantitative flow ratio, angiographic microvascular resistance
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFRDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | The VR-CP study cohort includes consecutive adult patients (≥18 years) who underwent coronary angiography for suspected ischemic heart disease and had at least one coronary lesion assessed by fractional flow reserve (FFR) or angiography-derived FFR. Receives: Diagnostic Test: Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel-Oriented Composite Endpoint (VOCE)
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.
Measured: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Secondary outcomes (6)
Cardiovascular death
Deaths attributed to cardiovascular causes, adjudicated according to ARC-2 definitions.
Measured: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Target vessel-related myocardial infarction
Myocardial infarction classified as related to the target vessel, defined by the 4th Universal Definition of MI.
Measured: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Target vessel revascularization
Any ischemia-driven percutaneous or surgical revascularization of the target vessel, based on symptoms, ischemia testing, or invasive physiology criteria.
Measured: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Hospitalization for unstable angina
Number and timing of hospital admissions due to unstable angina.
Measured: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Angina status (Seattle Angina Questionnaire)
Assessment of angina symptoms and quality of life using the validated Seattle Angina Questionnaire.
Measured: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Number of prescribed antianginal medications
Count of antianginal drugs prescribed to each patient during the follow-up period.
Measured: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start14 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Scarsini, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Roberto Scarsini, MD, PhD, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona (AOUI)Simone Fezzi, MD, Study chair, AOUI VeronaFlavio Ribichini, MD, Study chair, AOUI Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186582
- Sponsor's protocol ID
- VR-CP
- Acronym
- VR-CP
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, it has not yet been decided whether individual participant data (IPD) from this observational study will be shared with external researchers. Decisions on data sharing will be made considering ethical, legal, and institutional requirements. If a plan to share IPD is established, appropriate procedures for data access and privacy protection will be implemented.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verona Coronary Physiology Interventional Registry
- ClinicalTrials.gov ID
- NCT07186582
- Acronym / sponsor ID
- VR-CP / VR-CP
- Keywords
- Coronary Physiology, Fractional Flow Reserve (FFR), Radial Wall Strain, Intermediate Coronary Stenosis, Functional Coronary Angiography, Murray's law quantitative flow ratio, angiographic microvascular resistance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Diagnostic Test: Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFRThe VR-CP study cohort includes consecutive adult patients (≥18 years) who underwent coronary angiography for suspected ischemic heart disease and had at least one coronary lesion assessed by fractional flow reserve (FFR) or angiography-derived FFR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who underwent coronary angiography for suspected coronary artery disease with functional assessment (coronary physiology) performed from 2010 to 2024.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Impossibility to obtain informed consent
- Age < 18 years at the time of the index procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFRFunctional 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. | Diagnostic test | Study cohort |
Primary outcome
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.
6 secondary outcomes
Cardiovascular death
Time frame: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Target vessel-related myocardial infarction
Time frame: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Target vessel revascularization
Time frame: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Hospitalization for unstable angina
Time frame: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Angina status (Seattle Angina Questionnaire)
Time frame: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Number of prescribed antianginal medications
Time frame: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided. At present, it has not yet been decided whether individual participant data (IPD) from this observational study will be shared with external researchers. Decisions on data sharing will be made considering ethical, legal, and institutional requirements. If a plan to share IPD is established, appropriate procedures for data access and privacy protection will be implemented.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Scarsini, MD, PhD principal investigator
Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
Simone Fezzi, MD study chair
AOUI Verona
Flavio Ribichini, MD study chair
AOUI Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemic Heart Disease (IHD), run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel-Oriented Composite Endpoint (VOCE) (time frame: At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.