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临床试验/NCT01882114
NCT01882114Unknown不适用

Study of Atherosclerotic Risk Factors and Oxidative Stress in Atrial Fibrillation. Relation to Cardiovascular Events

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
Prevalence of metabolic syndrome in anticoagulated nonvalvular atrial fibrillation patients

研究概览

简要总结

The prevalence of metabolic syndrome in patients suffering from non valvular atrial fibrillation is derived from studies regarding recurrences of atrial fibrillation after catheter ablation. Prospective studies in european countries are lacking. Furthermore, the impact of metabolic syndrome on cardiovascular events in patients with non valvular atrial fibrillation is still unknown.

详细描述

Atrial fibrillation (AF) is the most common cardiac arrhythmia that is associated with a high risk of cardiovascular events and increased morbidity and mortality. Cardiovascular events are prevalently localized in the cerebral circulation in which AF is responsible for ischemic stroke. Clinical characteristics of ischemic stroke from AF are almost severe and thromboembolism is considered the most important cause. Thus, ischemic stroke is deemed to origin from thrombus formation generated in the left atrium with ensuing embolism in the cerebral circulation.

Patients with AF are typically associated with different risk factors of atherothrombosis including, overall, hypertension which may be detected in about 70-80% of the population; other risk factors are diabetes and dyslipidemia. This accounts for instrumental evidence of systemic atherosclerosis associated to AF. Thus, signs of atherosclerosis have been detected in the thoracic aorta, as represented by aortic plaque assessed by trans-esophageal echocardiography; patients with complex aortic plaque had fourfold increased rate of stroke compared to plaque-free patients.

Metabolic syndrome (MetS) is a constellation of atherosclerotic risk factors including, according to the modified National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII), hypertension, low HDL, impaired glycaemic control, hypertriglyceridemia and central obesity as assessed by waist circumference; the presence of MetS is associated with an increased risk of developing cardiac and cerebral ischemic events.

An higher risk to develop atrial fibrillation (AF) has been well recognized in patients with MetS. In a prospective, community-based, observational cohort study with annual health check-up 28449 subjects without AF the age-adjusted rates of AF were higher in subjects with compared to those without metabolic syndrome during a mean follow-up of 4.5 years.

Few studies reported on the prevalence of MetS in AF population are still lacking. Some data can be inferred from studies regarding recurrence of AF after catheter ablation reporting a prevalence ranging from 18.8% to 49.4% . The only population study so far published included 741 chinese patients and reported a prevalence of the MetS in AF of 46.3%. Taking into account the thresholds of waist circumference recommended by international societies for different ethnic groups, it is unclear if such prevalence can be extrapolated to population of western countries.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non valvular atrial fibrillation
  • age >18 years
  • any antithrombotic treatment

排除标准

  • prosthetic heart valves, or the presence of any severe valvulopathies, severe cognitive impairment, chronic infectious (HIV, hepatitis C, HBV) or autoimmune systemic disease. Furthermore, subjects were excluded from the study if they had active neoplastic diseases or liver insufficiency (eg, cirrhosis).

结局指标

主要结局

Prevalence of metabolic syndrome in anticoagulated nonvalvular atrial fibrillation patients

时间窗: At baseline

To assess the prevalence of metabolic syndrome in a population of patients suffering from nonvalvular atrial fibrillation receiving oral anticoagulants. The relationship between metabolic syndrome and vascular events will be described. Vascular events included a composite outcome of fatal and non fatal acute myocardial infarction, acute fatal and non fatal ischemic stroke, cardiac revascularization (stent/cabg), cardiovascular death.

次要结局

  • Echocardiographic characteristics in patients with paroxysmal or persistent/permanent atrial fibrillation(At baseline)
  • Progression of atherosclerosis in non valvular atrial fibrillation patients receiving oral anticoagulant therapy.(One year)
  • Determinants of Time in Therapeutic Range(Patients will be followed for an expected mean time of 25 months)
  • Analysis of oxidative stress markers in atrial fibrillation(At baseline)
  • Changing in glomerular filtration rate of anticoagulated patients with non valvular atrial fibrillation(One year)
  • Use of digoxin in atrial fibrillation(At baseline)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pasquale Pignatelli

Associate Professor

University of Roma La Sapienza

研究点 (1)

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