Clinical trial NCT05251012: 3D-QFR in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.
Official title: Three-dimensional Quantitative Flow Ratio (3D-QFR) in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Coronary Artery Disease
Keywords: Quantitative Flow Ratio
Coronary physiology
Computational physiology
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario Lozano Blesa
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Hospital General de Ciudad Real
name: Hospital de Leon
name: Hospital Universitario Virgen de la Arrixaca
First posted: 2022-02-22
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015.

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.


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.

Primary outcomes:
measure: To assess the 5-year prognosis of patients undergoing coronary angiography with confirmed or suspected diagnosis of stable coronary disease.
timeFrame: 5 years.
measure: 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.
timeFrame: 5 years.
measure: To determine number of percutaneous coronary intervention procedures performed on non-significant stenosis through QFR analysis and their prognosis.
timeFrame: 5 years.
measure: To evaluate the prognosis of non-revascularized and functionally significant coronary artery disease using QFR.
timeFrame: 5 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: