Identification of predictive plasma Biomarkers and use of a high dosage statin during a procedure of Parrossistic Atrial Fibrillation pharmacological Cardioversion - 2012-CARDAF

FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO0 个研究点开始时间: 2012年3月29日最近更新: 2012年7月3日

试验速览

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•1) patient between 18 and 75 years of age 2) patient able to understand the study aims and methods, to sign the informed consents relative to the part of the study he is willing to participate 3) patient showing the medical conditions that make a cardioversion procedure mandatory 4) patient whose clinical conditions allow to delay the cardioversion procedure for the time required to enroll the patients in the study (stable patient, that is not feeling extreme pain or anxiety for the condition related to the current episode of atrial fibrillation)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•1) hemodynamically unstable patient or bearing comorbidities precluding the possibility to complete the procedures of the study. 2) patient with diagnosis of class III-IV heart failure according to the NYHA classification 3) patients assuming chronically a statin at maximum dosage. 4) patient without hystory of statin intollerance characterized by: statin related myalgia and/or increase of specific enzymes elevation (CK > 2xULN; AST or ALT > 3x ULN) 5) patient assuming oral anticoagulant therapy 6) patient with affections determining intestinal malabsorption as: gastro-ileal by pass, gastric banding, other causes 7) patient with chronic kidney disease stage IV or more according to the NFK classification (calculated Glomerular filtrate rate < 30 ml/min) 8) patient with altered consciousness level, and/or a mental disease not adequately controlled by drug therapy.

发起方

FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO