Chronic Coronary SyndromeNCT05592535
Outcomes With Fractional Flow Reserve in Chronic Coronary Syndrome
An observational study of Chronic Coronary Syndrome, run by Uppsala University.
Trial summary
The use of fractional flow reserve (FFR) to assess the functional relevance of coronary stenoses has been demonstrated to reduce the risk urgent revascularization in chronic coronary syndrome patients.[1] The goal of this study is to assess whether the utility of using FFR during percutaneous coronary intervention… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Coronary revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic coronary syndrome undergoing coronary angiography and FFR measurement in Sweden.
Who may be able to join
- Chronic coronary syndrome undergoing coronary angiography and FFR measurement
- Swedish personal identification number
Who cannot join
- previous coronary artery bypass grafting
- left main disease or undergoing FFR/PCI of left main
- IVUS/OCT use
- diffuse disease (≥ 2 segments treated in a same vessel investigated with FFR, ≥ 2 segments investigated with FFR in a same vessel)
- PCI in a distal segment with respect to FFR measurements
About this study
Official title: Prognostic Impact of Fractional Flow Reserve in Chronic Coronary Syndrome: Quasi-Experimental Findings Using a Regression Discontinuity Design
The use of fractional flow reserve (FFR) to assess the functional relevance of coronary stenoses has been demonstrated to reduce the risk urgent revascularization in chronic coronary syndrome patients.[1] The goal of this study is to assess whether the utility of using FFR during percutaneous coronary intervention (PCI) in chronic coronary syndrome patients is confirmed in a real-life scenario. This study will implement a regression discontinuity design (RDD). RDD is a quasi-experimental study design able to provide robust findings on causality using observational data.
Read the detailed description
All patients in this study were included in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), a sub-registry of SWEDEHEART. [2] Data regarding FFR assessments are documented in SCAAR in terms of FFR values and coronary segments investigated with FFR. The use of FFR during PCI is left at the discretion of the operator. Since a nondeterministic assignment to revascularization is expected at the cut-off, a fuzzy RDD design will be used in the analyses. Moreover, FFR values equal to 0.80 (at the cut-off) will be excluded from the analysis since treatment assignment exactly at the cut-off may substantially vary across operators and this may create distortions in the treatment discontinuity. Local linear regression estimates with Kernel triangulation and asymmetric bandwidth selection will be used in the analysis. Bandwidth selection will be based on a fully data-driven approach that minimizes the bias-variance trade-off.[3] Estimates from RDD will be presented as risk differences [RD] complemented by 95% robust confidence intervals.[4]
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Coronary revascularization
- Keywords
- Percutaneous Coronary Intervention, Fractional Flow Reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary revascularizationProcedure or surgery
Coronary revascularization performed by PCI in a vessel investigated with FFR or indication for surgery
| Study group | Role | What they receive |
|---|---|---|
| FFR below 0.80 | Patients with significant coronary hyperemic gradient Receives: Procedure: Coronary revascularization | |
| FFR above 0.80 | Patients without significant coronary hyperemic gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI
Measured: Up to one year following index FFR measurement
Secondary outcomes (3)
Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarction
Measured: Up to one year following index FFR measurement
Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarction
Measured: Up to one year following index FFR measurement
Risk differences (%) for the individual components of the composite outcome measures
Measured: Up to one year following index FFR measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Jun 2015
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592535
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
PubMed 22924638Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L. The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart. 2010 Oct;96(20):1617-21. doi: 10.1136/hrt.2010.198804. Epub 2010 Aug 27.
PubMed 20801780Calonico S, Cattaneo MD, Farrell MH. Optimal bandwidth choice for robust bias corrected inference in regression discontinuity designs. Econom J. 2020;23(2):192-210.
Calonico S, Cattaneo MD, Titiunik R. Robust nonparametric confidence intervals for regression-discontinuity designs. Econometrica. 2014;82(6):2295-2326.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Fractional Flow Reserve in Chronic Coronary Syndrome: Quasi-Experimental Findings Using a Regression Discontinuity Design
- ClinicalTrials.gov ID
- NCT05592535
- Acronym / sponsor ID
- 1
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Percutaneous Coronary Intervention, Fractional Flow Reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 24 Oct 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.
The use of fractional flow reserve (FFR) to assess the functional relevance of coronary stenoses has been demonstrated to reduce the risk urgent revascularization in chronic coronary syndrome patients.[1] The goal of this study is to assess whether the utility of using FFR during percutaneous coronary intervention (PCI) in chronic coronary syndrome patients is confirmed in a real-life scenario. This study will implement a regression discontinuity design (RDD). RDD is a quasi-experimental study design able to provide robust findings on causality using observational data.
Detailed description
All patients in this study were included in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), a sub-registry of SWEDEHEART. [2] Data regarding FFR assessments are documented in SCAAR in terms of FFR values and coronary segments investigated with FFR. The use of FFR during PCI is left at the discretion of the operator. Since a nondeterministic assignment to revascularization is expected at the cut-off, a fuzzy RDD design will be used in the analyses. Moreover, FFR values equal to 0.80 (at the cut-off) will be excluded from the analysis since treatment assignment exactly at the cut-off may substantially vary across operators and this may create distortions in the treatment discontinuity. Local linear regression estimates with Kernel triangulation and asymmetric bandwidth selection will be used in the analysis. Bandwidth selection will be based on a fully data-driven approach that minimizes the bias-variance trade-off.[3] Estimates from RDD will be presented as risk differences [RD] complemented by 95% robust confidence intervals.[4]
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR below 0.80 | – | Procedure: Coronary revascularizationPatients with significant coronary hyperemic gradient |
| FFR above 0.80 | – | –Patients without significant coronary hyperemic gradient |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic coronary syndrome undergoing coronary angiography and FFR measurement in Sweden.
Key inclusion criteria (2 listed)
- Chronic coronary syndrome undergoing coronary angiography and FFR measurement
- Swedish personal identification number
Key exclusion criteria (5 listed)
- previous coronary artery bypass grafting
- left main disease or undergoing FFR/PCI of left main
- IVUS/OCT use
- diffuse disease (≥ 2 segments treated in a same vessel investigated with FFR, ≥ 2 segments investigated with FFR in a same vessel)
- PCI in a distal segment with respect to FFR measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary revascularizationCoronary revascularization performed by PCI in a vessel investigated with FFR or indication for surgery | Procedure or surgery | FFR below 0.80 |
Primary outcome
Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI
Time frame: Up to one year following index FFR measurement
3 secondary outcomes
Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarction
Time frame: Up to one year following index FFR measurement
Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarction
Time frame: Up to one year following index FFR measurement
Risk differences (%) for the individual components of the composite outcome measures
Time frame: Up to one year following index FFR measurement
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 24 Oct 2022.
- Background: PubMed 22924638De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
- Background: PubMed 20801780Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L. The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart. 2010 Oct;96(20):1617-21. doi: 10.1136/hrt.2010.198804. Epub 2010 Aug 27.
- BackgroundCalonico S, Cattaneo MD, Farrell MH. Optimal bandwidth choice for robust bias corrected inference in regression discontinuity designs. Econom J. 2020;23(2):192-210.
- BackgroundCalonico S, Cattaneo MD, Titiunik R. Robust nonparametric confidence intervals for regression-discontinuity designs. Econometrica. 2014;82(6):2295-2326.
- Individual participant dataSharing planned: No
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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 Chronic Coronary Syndrome, run by Uppsala University.
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 2 inclusion and 5 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 24 Oct 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?
Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI (time frame: Up to one year following index FFR measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592535, which also lists 4 linked publications.
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 24 Oct 2022.