Chronic Coronary Syndrome Clinical Trial
Official title:
Prognostic Impact of Fractional Flow Reserve in Chronic Coronary Syndrome: Quasi-Experimental Findings Using a Regression Discontinuity Design
NCT number | NCT05592535 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2015 |
Est. completion date | June 1, 2020 |
Verified date | October 2022 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 5000 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Chronic coronary syndrome undergoing coronary angiography and FFR measurement - Swedish personal identification number Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Uppsala University |
Calonico 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.
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Möbius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Jüni 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. Erratum in: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Möbius-Winkler, Sven]. — View Citation
Jernberg 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI | Up to one year following index FFR measurement | ||
Secondary | Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarction | Up to one year following index FFR measurement | ||
Secondary | Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarction | Up to one year following index FFR measurement | ||
Secondary | Risk differences (%) for the individual components of the composite outcome measures | Up to one year following index FFR measurement |
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