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Atherosclerosis in Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01882114
Recruitment Status : Recruiting
First Posted : June 20, 2013
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Pasquale Pignatelli, University of Roma La Sapienza

Brief Summary:
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.

Condition or disease
Atrial Fibrillation Metabolic Syndrome Oxidative Stress Atherosclerosis Disorders, Blood Coagulation

Detailed Description:

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.

Furthermore the impact of MetS on the incidence of cardiovascular events in patients with non valvular AF (NVAF) taking oral anticoagulant therapy (OAT) has never been investigated.

Therefore, our aim was to investigate the prevalence of MetS in a population of NVAF patients under oral coagulation treatment and its impact on cardiovascular events during a prospective study.

The study has been modified and approved by local ethical board of Sapienza University of Rome to include patients treated with non-vitamin K oral anticoagulants (dabigatran, apixaban, edoxaban, rivaroxaban) on April 11, 2014 (Prot. 417/14).

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Atherosclerotic Risk Factors and Oxidative Stress in Atrial Fibrillation. Relation to Cardiovascular Events
Study Start Date : November 2007
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Prevalence of metabolic syndrome in anticoagulated nonvalvular atrial fibrillation patients [ Time Frame: 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.

Secondary Outcome Measures :
  1. Progression of atherosclerosis in non valvular atrial fibrillation patients receiving oral anticoagulant therapy. [ Time Frame: One year ]
    To assess the progression of atherosclerosis in nonvalvular atrial fibrillation patients defined by some surrogate markers. In particular ankle brachial index, intima media thickness, flow mediated dilation and transthoracic echocardiogram will be performed to all enrolled patients.

  2. Analysis of oxidative stress markers in atrial fibrillation [ Time Frame: At baseline ]
    Oxidative stress markers such as plasmatic and urinary isoprostanes, thromboxane, platelet recruitment, reactive species of oxygen, nadph oxidase(nox2)will be measured. Differences of these markers among patients experiencing or not a vascular outcome will be described

  3. Changing in glomerular filtration rate of anticoagulated patients with non valvular atrial fibrillation [ Time Frame: One year ]
    To assess changes in renal function after one year of follow up in patients with non valvular atrial fibrillation receiving oral anticoagulants

  4. Determinants of Time in Therapeutic Range [ Time Frame: Patients will be followed for an expected mean time of 25 months ]
    To assess the determinants of time in therapeutic range (TTR) in patients receiving oral anticoagulants

  5. Use of digoxin in atrial fibrillation [ Time Frame: At baseline ]
    Use of digoxin will be assessed at baseline. The relationship with vascular outcomes will be described

  6. Echocardiographic characteristics in patients with paroxysmal or persistent/permanent atrial fibrillation [ Time Frame: At baseline ]
    Transthoracic echocardiography will be performed at baseline. Morphologic and functional measures will be registered. The relationship with vascular outcome will be described

Other Outcome Measures:
  1. Mediterranean diet adherence in non valvular atrial fibrillation [ Time Frame: At baseline ]
    To assess the adherence to the mediterranean diet in patients receiving oral anticoagulants

Biospecimen Retention:   Samples With DNA
After overnight fasting and supine rest for at least 10 minutes, blood was withdrawn from the antecubital vein. Serum was divided into aliquots and stored at -80°C.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective single-center study including consecutive patients with NVAF referring to our center for monitoring and management of antithrombotic therapies of the Department of Internal Medicine and Medical Specialties of Sapienza-University of Rome from November 2007.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01882114

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Umberto I Policlinico di Roma, Sapienza Università di Roma Recruiting
Rome, Italy, 00155
Contact: Pasquale Pignatelli, MD    +390649970893   
Contact: Daniele Pastori, MD    +390649970893   
Principal Investigator: Pasquale Pignatelli, MD         
Principal Investigator: Daniele Pastori, MD         
Sponsors and Collaborators
University of Roma La Sapienza
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Study Director: Francesco Violi, Prof Sapienza Università di Roma
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pasquale Pignatelli, Associate Professor, University of Roma La Sapienza Identifier: NCT01882114    
Other Study ID Numbers: MetS1306/2007
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Pasquale Pignatelli, University of Roma La Sapienza:
cardiovascular events
ankle-brachial index
carotid disease
mediterranean diet
platelet activation
Additional relevant MeSH terms:
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Atrial Fibrillation
Hemostatic Disorders
Blood Coagulation Disorders
Metabolic Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Hematologic Diseases
Hemorrhagic Disorders