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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05251012

Enrollment

803

Registered

2022-02-22

Start date

2015-01-01

Completion date

2019-12-31

Last updated

2022-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Stenosis

Keywords

Quantitative Flow Ratio, Coronary physiology, Computational physiology

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
To determine number of percutaneous coronary intervention procedures performed on non-significant stenosis through QFR analysis and their prognosis.	5 years.
To assess the 5-year prognosis of patients undergoing coronary angiography with confirmed or suspected diagnosis of stable coronary disease.	5 years.
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.
To evaluate the prognosis of non-revascularized and functionally significant coronary artery disease using QFR.	5 years.

Outcome results