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Instantaneous Wave-...
Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART) : Rationale and design of a multicenter, prospective, registry-based randomized clinical trial
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- Götberg, Matthias (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Christiansen, Evald H. (author)
- Department of Cardiology, Aarhus University Hospital, Skejby, Denmark,Aarhus Univ Hosp, Dept Cardiol, Skejby, Denmark.
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- Gudmundsdottir, Ingibjorg (author)
- Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland,Reykjavik Univ Hosp, Dept Cardiol, Reykjavik, Iceland.
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- Sandhall, Lennart (author)
- Department of Radiology, Helsingborg County Hospital, Helsingborg, Sweden,Helsingborg Cty Hosp, Dept Radiol, Helsingborg, Sweden.
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- Omerovic, Elmir, 1968 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
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- James, Stefan K. (author)
- Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR),Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
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- Erlinge, David (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Fröbert, Ole, 1964- (author)
- Örebro universitet,Institutionen för hälsovetenskap och medicin,Univ Orebro, Fac Hlth, Dept Cardiol, SE-70182 Orebro, Sweden.
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(creator_code:org_t)
- Mosby-Elsevier, 2015
- 2015
- English.
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In: American Heart Journal. - : Mosby-Elsevier. - 0002-8703 .- 1097-6744. ; 170:5, s. 945-950
- Related links:
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http://dx.doi.org/10...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://lup.lub.lu.s...
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Abstract
Subject headings
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- Background: Instantaneous 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.Design/Methods: iFR-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.Discussion: The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Cardiology
- Kardiologi
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Götberg, Matthia ...
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Christiansen, Ev ...
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Gudmundsdottir, ...
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Sandhall, Lennar ...
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Omerovic, Elmir, ...
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James, Stefan K.
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Erlinge, David
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Fröbert, Ole, 19 ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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American Heart J ...
- By the university
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Örebro University
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Uppsala University
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Lund University
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University of Gothenburg