Coronary StenosisNCT05251012
3D-QFR in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.
An observational study of Coronary Stenosis and Coronary Artery Disease, run by Pablo Manuel Fernandez Corredoira.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Stenosis, Coronary Artery Disease
- How many people
- 803 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015.
Who cannot join
- 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.
About this study
Official title: Three-dimensional Quantitative Flow Ratio (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.
Read more
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.
- Conditions
- Coronary Stenosis, Coronary Artery Disease
- Keywords
- Quantitative Flow Ratio, Coronary physiology, Computational physiology
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the 5-year prognosis of patients undergoing coronary angiography with confirmed or suspected diagnosis of stable coronary disease.
Measured: 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.
Measured: 5 years.
To determine number of percutaneous coronary intervention procedures performed on non-significant stenosis through QFR analysis and their prognosis.
Measured: 5 years.
To evaluate the prognosis of non-revascularized and functionally significant coronary artery disease using QFR.
Measured: 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pablo Manuel Fernandez Corredoira
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario Lozano Blesa, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital General de Ciudad Real, Hospital de Leon, Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Sponsor-investigator, Pablo Manuel Fernandez Corredoira, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251012
- Sponsor's protocol ID
- 1.1
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Quantitative Flow Ratio (3D-QFR) in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.
- ClinicalTrials.gov ID
- NCT05251012
- Acronym / sponsor ID
- 1.1
- Conditions
- Coronary Stenosis, Coronary Artery Disease
- Keywords
- Quantitative Flow Ratio, Coronary physiology, Computational physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Pablo Manuel Fernandez CorredoiraUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario Lozano Blesa, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital General de Ciudad Real, Hospital de Leon, Hospital Universitario Virgen de la Arrixaca
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis and Coronary Artery Disease, run by Pablo Manuel Fernandez Corredoira.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the 5-year prognosis of patients undergoing coronary angiography with confirmed or suspected diagnosis of stable coronary disease. (time frame: 5 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.