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- Atar, Dan, et al.
(författare)
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Rationale and Design of the 'MITOCARE' Study: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRO40303 for the Reduction of Reperfusion Injury in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction
- 2012
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Ingår i: Cardiology. - : S. Karger AG. - 1421-9751 .- 0008-6312. ; 123:4, s. 201-207
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Tidskriftsartikel (refereegranskat)abstract
- Treatment of acute ST-elevation myocardial infarction (STEMI) by reperfusion using percutaneous coronary intervention (PCI) or thrombolysis has provided clinical benefits; however, it also induces considerable cell death. This process is called reperfusion injury. The continuing high rates of mortality and heart failure after acute myocardial infarction (AMI) emphasize the need for improved strategies to limit reperfusion injury and improve clinical outcomes. The objective of this study is to assess safety and efficacy of TRO40303 in limiting reperfusion injury in patients treated for STEMI. TRO40303 targets the mitochondrial permeability transition pore, a promising target for the prevention of reperfusion injury. This multicenter, double-blind study will randomize patients with STEMI to TRO40303 or placebo administered just before balloon inflation or thromboaspiration during PCI. The primary outcome measure will be reduction in infarct size (assessed as plasma creatine kinase and troponin I area under the curve over 3 days). The main secondary endpoint will be infarct size normalized to the myocardium at risk (expressed by the myocardial salvage index assessed by cardiac magnetic resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better understanding of the complex pathophysiology underlying myocardial injury after STEMI. The present paper describes the rationale, design and the methods of the trial. Copyright (c) 2012 S. Karger AG, Basel
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| 2. |
- Oterhals, Kjersti, et al.
(författare)
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Adapting to living with a mechanical aortic heart valve : a phenomenographic study
- 2013
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Ingår i: Journal of Advanced Nursing. - : Wiley. - 0309-2402 .- 1365-2648. ; 69:9, s. 2088-2098
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Tidskriftsartikel (refereegranskat)abstract
- AimTo describe how patients adapt to living with a mechanical aortic heart valve.BackgroundAortic valve replacement with a mechanical prosthesis is preferred for patients with life expectancy of more than 10 years as they are more durable than bioprosthetic valves. Mechanical valves have some disadvantages, such as higher risk of thrombosis and embolism, increased risk of bleeding related to lifelong oral anticoagulation treatment and noise from the valve.DesignAn explorative design with a phenomenographic approach was employed.MethodsAn explorative design with a phenomenographic approach was applied. Interviews were conducted over 4 months during 2010–2011 with 20 strategically sampled patients, aged 24–74 years having undergone aortic valve replacement with mechanical prosthesis during the last 10 years.FindingsPatients adapted to living with a mechanical aortic heart valve in four ways: ‘The competent patient’ wanted to stay in control of his/her life. ‘The adjusted patient’ considered the implications of having a mechanical aortic valve as part of his/her daily life. ‘The unaware patient’ was not aware of warfarin–diet–medication interactions. ‘The worried patient’ was bothered with the oral anticoagulation and annoyed by the sound of the valve. Patients moved between the different ways of adapting.ConclusionsThe oral anticoagulation therapy was considered the most troublesome consequence, but also the sound of the valve was difficult to accept. Patient counselling and adequate follow-up can make patients with mechanical aortic heart valves more confident and competent to manage their own health. We recommend that patients should participate in a rehabilitation programme following cardiac surgery.
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