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.
1 other identifier
observational
803
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedFebruary 22, 2022
February 1, 2022
5 years
February 11, 2022
February 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 determine number of percutaneous coronary intervention procedures performed on non-significant stenosis through QFR analysis and their prognosis.
5 years.
To evaluate the prognosis of non-revascularized and functionally significant coronary artery disease using QFR.
5 years.
Eligibility 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.
You may qualify if:
- Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pablo Manuel Fernandez Corredoiralead
- Hospital Clínico Universitario Lozano Blesacollaborator
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesacollaborator
- Hospital General de Ciudad Realcollaborator
- Hospital de Leoncollaborator
- Hospital Universitario Virgen de la Arrixacacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Cardiology resident
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 22, 2022
Study Start
January 1, 2015
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 22, 2022
Record last verified: 2022-02