3D-QFR in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.

NCT ID: NCT05251012

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 803 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2019-12-31

Brief Summary

Physiology-based decision-making about the need for revascularisation in patients with stable coronary heart disease has consistently proven better clinical outcomes than a merely anatomical approach. However, against the current recommendations, revascularisation in most of patients with chronic coronary syndromes still relies on coronary angiography alone. The increase in costs and in procedural complexity of wire-based physiology may explain the latter. Therefore, a novel non-invasive functional quantitative flow ratio (QFR) index was created in order to solve it.

A retrospective and multicentre study is performed to assess the 5-year prognosis of patients undergoing coronary angiography through a centralized QFR analysis. Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015 were included.

Aims of the study:

• To evaluate the prognosis of stable coronary disease depending on the functional assessment of coronary artery disease.
• To determine the % of percutaneous coronary interventions that could be avoided if this study had been carried out through functional assessment of coronary artery disease based on 3-dimensional vessel reconstruction.

Conditions

Coronary Stenosis; Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015.

Exclusion Criteria

1. Previous coronary artery bypass grafting.

2. <18 years or >90 years.

3. Angiographic acquisitions that make it impracticable to perform QFR analysis (patients will be included for descriptive purposes).

4. If a patient has undergone several unscheduled coronary angiographies during the study period, the first will be included as the index case and the following as a follow-up event.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clínico Universitario Lozano Blesa

OTHER

Sponsor Role: collaborator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: collaborator

Hospital General de Ciudad Real

OTHER

Sponsor Role: collaborator

Hospital de Leon

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role: collaborator

Pablo Manuel Fernandez Corredoira

OTHER

Sponsor Role: lead

Responsible Party

Pablo Manuel Fernandez Corredoira

Cardiology resident

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

1.1

Identifier Type: -

Identifier Source: org_study_id