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

Coronary Artery Disease Clinical Trial

Official title:

Three-dimensional Quantitative Flow Ratio (3D-QFR) in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251012
• Other study ID #: 1.1
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2022
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Stenosis

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Pablo Manuel Fernandez Corredoira	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Clínico Universitario Lozano Blesa, Hospital de Leon, Hospital General de Ciudad Real, Hospital Universitario Virgen de la Arrixaca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the 5-year prognosis of patients undergoing coronary angiography with confirmed or suspected diagnosis of stable coronary disease.		5 years.
Primary	To define the functional index of revascularized and non-revascularized coronary stenosis and to analyse the prognosis according to the result and the treatment performed.		5 years.
Primary	To determine number of percutaneous coronary intervention procedures performed on non-significant stenosis through QFR analysis and their prognosis.		5 years.
Primary	To evaluate the prognosis of non-revascularized and functionally significant coronary artery disease using QFR.		5 years.