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

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.

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Key information

Conditions

Coronary Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Previous coronary artery bypass grafting.
<18 years or >90 years.
Angiographic acquisitions that make it impracticable to perform QFR analysis (patients will be included for descriptive purposes).
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.

Treatment and study plan

Primary outcomes

To assess the 5-year prognosis of patients undergoing coronary angiography with confirmed or suspected diagnosis of stable coronary disease.

Time frame: 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.

Time frame: 5 years.
To determine number of percutaneous coronary intervention procedures performed on non-significant stenosis through QFR analysis and their prognosis.

Time frame: 5 years.
To evaluate the prognosis of non-revascularized and functionally significant coronary artery disease using QFR.

Time frame: 5 years.

Sponsors and collaborators

Lead sponsor

Pablo Manuel Fernandez Corredoira

Other

Collaborators

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital Clínico Universitario Lozano Blesa
Hospital General de Ciudad Real
Hospital Universitario Virgen de la Arrixaca
Hospital de Leon

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Feb 22, 2022
Registry last updated: Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed