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dc.contributor.authorGötberg, Matthias
dc.contributor.authorChristiansen, Evald H
dc.contributor.authorGudmundsdottir, Ingibjörg
dc.contributor.authorSandhall, Lennart
dc.contributor.authorOmerovic, Elmir
dc.contributor.authorJames, Stefan K
dc.contributor.authorErlinge, David
dc.contributor.authorFröbert, Ole
dc.date.accessioned2016-01-04T13:42:45Zen
dc.date.available2016-01-04T13:42:45Zen
dc.date.issued2015-11en
dc.date.submitted2015en
dc.identifier.citationInstantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. 2015, 170 (5):945-50 Am. Heart J.en
dc.identifier.issn1097-6744en
dc.identifier.pmid26542503en
dc.identifier.doi10.1016/j.ahj.2015.07.031en
dc.identifier.urihttp://hdl.handle.net/2336/592750en
dc.descriptionTo access publisher's full text version of this article click on the hyperlink at the bottom of the pageen
dc.description.abstractInstantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up.
dc.description.abstractiFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality.
dc.description.abstractThe iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.
dc.description.sponsorshipVolcano Corporationen
dc.language.isoenen
dc.publisherMosby-Elsevieren
dc.relation.urlhttp://dx.doi.org/ 10.1016/j.ahj.2015.07.031en
dc.rightsArchived with thanks to American heart journalen
dc.subject.meshPercutaneous Coronary Interventionen
dc.subject.meshMyocardial Infarctionen
dc.subject.meshAngiographyen
dc.subject.meshAdenosineen
dc.subject.meshCoronary Stenosisen
dc.subject.meshAngioplastyen
dc.subject.meshClassificationen
dc.titleInstantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.en
dc.typeArticleen
dc.contributor.department[ 1 ] Lund Univ, Skane Univ Hosp, Dept Cardiol, S-22185 Lund, Sweden [ 2 ] Aarhus Univ Hosp, Dept Cardiol, Skejby, Denmark [ 3 ] Reykjavik Univ Hosp, Dept Cardiol, Reykjavik, Iceland   Organization-Enhanced Name(s)      Landspitali National University Hospital [ 4 ] Helsingborg Cty Hosp, Dept Radiol, Helsingborg, Sweden [ 5 ] Sahlgrenska Univ, Dept Cardiol, Gothenburg, Sweden [ 6 ] Uppsala Univ, Dept Med Sci, Cardiol, Uppsala, Sweden [ 7 ] Uppsala Univ, Uppsala Clin Res Ctr, Uppsala, Sweden [ 8 ] Univ Orebro, Fac Hlth, Dept Cardiol, SE-70182 Orebro, Swedenen
dc.identifier.journalAmerican heart journalen
dc.rights.accessNational Consortium - Landsaðganguren
html.description.abstractInstantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up.
html.description.abstractiFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality.
html.description.abstractThe iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.


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