Verona Coronary Physiology Interventional Registry

NCT07186582 | Active Not Recruiting

• 1 other identifier: VR-CP
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease (IHD); Coronary Heart Disease (CHD)

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At 12 months, and every 12 months thereafter up to 10 years after index coronary angiography

Secondary Outcomes (6)

• 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

Study Arms (1)

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.

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

Interventions

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.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who underwent coronary angiography for suspected coronary artery disease with functional assessment (coronary physiology) performed from 2010 to 2024.

You may qualify if:

• 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

You may not qualify if:

• Impossibility to obtain informed consent
• Age \< 18 years at the time of the index procedure

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona(AOUI)

Verona, VR, 37126, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Roberto Scarsini, MD, PhD

  Azienda Ospedaliera Universitaria Integrata Verona (AOUI)

  PRINCIPAL INVESTIGATOR

• Simone Fezzi, MD

  AOUI Verona

  STUDY CHAIR

• Flavio Ribichini, MD

  AOUI Verona

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 22, 2025
• Study Start: July 14, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2034
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

IT (1)