Atrial FibrillationNCT01882114
Atherosclerosis in Atrial Fibrillation
An observational study of Atrial Fibrillation and Metabolic Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Metabolic Syndrome, Oxidative Stress
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- non valvular atrial fibrillation
- age >18 years
- any antithrombotic treatment
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Umberto I Policlinico di Roma, Sapienza Università di Roma
Rome, 00155
Pasquale Pignatelli, MD, +390649970893, pasquale.pignatelli@uniroma1.it
Daniele Pastori, MD, +390649970893, daniele.pastori@uniroma1.it
About this study
Official title: Study of Atherosclerotic Risk Factors and Oxidative Stress in Atrial Fibrillation. Relation to Cardiovascular Events
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.
Read the 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).
- Conditions
- Atrial Fibrillation, Metabolic Syndrome, Oxidative Stress, Atherosclerosis, Disorders, Blood Coagulation
- Keywords
- atherosclerosis, cardiovascular events, ankle-brachial index, carotid disease, echocardiography, mediterranean diet, platelet activation
- Medical subject headings
- Atrial Fibrillation, Metabolic Syndrome, Atherosclerosis, Blood Coagulation Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of metabolic syndrome in anticoagulated nonvalvular atrial fibrillation patients
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.
Measured: At baseline
Secondary outcomes (6)
Progression of atherosclerosis in non valvular atrial fibrillation patients receiving oral anticoagulant therapy.
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.
Measured: One year
Analysis of oxidative stress markers in atrial fibrillation
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
Measured: At baseline
Changing in glomerular filtration rate of anticoagulated patients with non valvular atrial fibrillation
To assess changes in renal function after one year of follow up in patients with non valvular atrial fibrillation receiving oral anticoagulants
Measured: One year
Determinants of Time in Therapeutic Range
To assess the determinants of time in therapeutic range (TTR) in patients receiving oral anticoagulants
Measured: Patients will be followed for an expected mean time of 25 months
Use of digoxin in atrial fibrillation
Use of digoxin will be assessed at baseline. The relationship with vascular outcomes will be described
Measured: At baseline
Echocardiographic characteristics in patients with paroxysmal or persistent/permanent atrial fibrillation
Transthoracic echocardiography will be performed at baseline. Morphologic and functional measures will be registered. The relationship with vascular outcome will be described
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startNov 2007
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Pignatelli, University of Roma La Sapienza
- Investigators
- Francesco Violi, Prof, Study director, Sapienza Università di Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882114
- Sponsor's protocol ID
- MetS1306/2007
- Status last verified
- Feb 2018
- First submitted
- 24 May 2013
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Pignatelli P, Pastori D, Farcomeni A, Nocella C, Bartimoccia S, Vicario T, Bucci T, Carnevale R, Violi F. Mediterranean diet reduces thromboxane A2 production in atrial fibrillation patients. Clin Nutr. 2015 Oct;34(5):899-903. doi: 10.1016/j.clnu.2014.09.011. Epub 2014 Sep 28.
PubMed 25288566Pignatelli P, Pastori D, Carnevale R, Farcomeni A, Cangemi R, Nocella C, Bartimoccia S, Vicario T, Saliola M, Lip GY, Violi F. Serum NOX2 and urinary isoprostanes predict vascular events in patients with atrial fibrillation. Thromb Haemost. 2015 Mar;113(3):617-24. doi: 10.1160/TH14-07-0571. Epub 2014 Nov 13.
PubMed 25392853Pastori D, Pignatelli P, Angelico F, Farcomeni A, Del Ben M, Vicario T, Bucci T, Raparelli V, Cangemi R, Tanzilli G, Lip GYH, Violi F. Incidence of myocardial infarction and vascular death in elderly patients with atrial fibrillation taking anticoagulants: relation to atherosclerotic risk factors. Chest. 2015 Jun;147(6):1644-1650. doi: 10.1378/chest.14-2414.
PubMed 25429521Pastori D, Farcomeni A, Bucci T, Cangemi R, Ciacci P, Vicario T, Violi F, Pignatelli P. Digoxin treatment is associated with increased total and cardiovascular mortality in anticoagulated patients with atrial fibrillation. Int J Cardiol. 2015 Feb 1;180:1-5. doi: 10.1016/j.ijcard.2014.11.112. Epub 2014 Nov 18.
PubMed 25460369Pastori D, Carnevale R, Bartimoccia S, Nocella C, Tanzilli G, Cangemi R, Vicario T, Catena M, Violi F, Pignatelli P. Does Mediterranean Diet Reduce Cardiovascular Events and Oxidative Stress in Atrial Fibrillation? Antioxid Redox Signal. 2015 Sep 10;23(8):682-7. doi: 10.1089/ars.2015.6326. Epub 2015 Apr 28.
PubMed 25825798Pignatelli P, Pastori D, Vicario T, Bucci T, Del Ben M, Russo R, Tanzilli A, Nardoni ML, Bartimoccia S, Nocella C, Ferro D, Saliola M, Cangemi R, Lip GY, Violi F. Relationship between Mediterranean diet and time in therapeutic range in atrial fibrillation patients taking vitamin K antagonists. Europace. 2015 Aug;17(8):1223-8. doi: 10.1093/europace/euv127. Epub 2015 May 19.
PubMed 25995397Pastori D, Pignatelli P, Saliola M, Carnevale R, Vicario T, Del Ben M, Cangemi R, Barilla F, Lip GY, Violi F. Inadequate anticoagulation by Vitamin K Antagonists is associated with Major Adverse Cardiovascular Events in patients with atrial fibrillation. Int J Cardiol. 2015 Dec 15;201:513-6. doi: 10.1016/j.ijcard.2015.08.054. Epub 2015 Aug 5.
PubMed 26318513Pastori D, Pignatelli P, Farcomeni A, Cangemi R, Hiatt WR, Bartimoccia S, Nocella C, Vicario T, Bucci T, Carnevale R, Lip GY, Violi F. Urinary 11-dehydro-thromboxane B2 is associated with cardiovascular events and mortality in patients with atrial fibrillation. Am Heart J. 2015 Sep;170(3):490-7.e1. doi: 10.1016/j.ahj.2015.05.011. Epub 2015 May 22.
PubMed 26385032Pastori D, Farcomeni A, Poli D, Antonucci E, Angelico F, Del Ben M, Cangemi R, Tanzilli G, Lip GY, Pignatelli P, Violi F. Cardiovascular risk stratification in patients with non-valvular atrial fibrillation: the 2MACE score. Intern Emerg Med. 2016 Mar;11(2):199-204. doi: 10.1007/s11739-015-1326-1. Epub 2015 Oct 15.
PubMed 26471883Pastori D, Pignatelli P, Perticone F, Sciacqua A, Carnevale R, Farcomeni A, Basili S, Corazza GR, Davi G, Lip GYH, Violi F; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) study group. Aspirin and renal insufficiency progression in patients with atrial fibrillation and chronic kidney disease. Int J Cardiol. 2016 Nov 15;223:619-624. doi: 10.1016/j.ijcard.2016.08.224. Epub 2016 Aug 14.
PubMed 27565838Pastori D, Pignatelli P, Farcomeni A, Menichelli D, Nocella C, Carnevale R, Violi F. Aging-Related Decline of Glutathione Peroxidase 3 and Risk of Cardiovascular Events in Patients With Atrial Fibrillation. J Am Heart Assoc. 2016 Sep 8;5(9):e003682. doi: 10.1161/JAHA.116.003682.
PubMed 27609361Pastori D, Pignatelli P, Farcomeni A, Nocella C, Bartimoccia S, Carnevale R, Violi F. Age-related increase of thromboxane B2 and risk of cardiovascular disease in atrial fibrillation. Oncotarget. 2016 Jun 28;7(26):39143-39147. doi: 10.18632/oncotarget.9826.
PubMed 27270651Pastori D, Carnevale R, Menichelli D, Nocella C, Bartimoccia S, Novo M, Leo I, Violi F, Pignatelli P. Is There an Interplay Between Adherence to Mediterranean Diet, Antioxidant Status, and Vascular Disease in Atrial Fibrillation Patients? Antioxid Redox Signal. 2016 Nov 10;25(14):751-755. doi: 10.1089/ars.2016.6839. Epub 2016 Sep 30.
PubMed 27577528Pastori D, Carnevale R, Nocella C, Novo M, Santulli M, Cammisotto V, Menichelli D, Pignatelli P, Violi F. Gut-Derived Serum Lipopolysaccharide is Associated With Enhanced Risk of Major Adverse Cardiovascular Events in Atrial Fibrillation: Effect of Adherence to Mediterranean Diet. J Am Heart Assoc. 2017 Jun 5;6(6):e005784. doi: 10.1161/JAHA.117.005784.
PubMed 28584074Carnevale R, Pignatelli P, Frati G, Nocella C, Stanzione R, Pastori D, Marchitti S, Valenti V, Santulli M, Barbato E, Strisciuglio T, Schirone L, Vecchione C, Violi F, Volpe M, Rubattu S, Sciarretta S. C2238 ANP gene variant promotes increased platelet aggregation through the activation of Nox2 and the reduction of cAMP. Sci Rep. 2017 Jun 19;7(1):3797. doi: 10.1038/s41598-017-03679-9.
PubMed 28630469
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Atherosclerotic Risk Factors and Oxidative Stress in Atrial Fibrillation. Relation to Cardiovascular Events
- ClinicalTrials.gov ID
- NCT01882114
- Acronym / sponsor ID
- MetS1306/2007
- Conditions
- Atrial Fibrillation, Metabolic Syndrome, Oxidative Stress, Atherosclerosis, Disorders, Blood Coagulation
- Keywords
- atherosclerosis, cardiovascular events, ankle-brachial index, carotid disease, echocardiography, mediterranean diet, platelet activation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- non valvular atrial fibrillation
- age >18 years
- any antithrombotic treatment
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Progression of atherosclerosis in non valvular atrial fibrillation patients receiving oral anticoagulant therapy.
Time frame: One year
Analysis of oxidative stress markers in atrial fibrillation
Time frame: At baseline
Changing in glomerular filtration rate of anticoagulated patients with non valvular atrial fibrillation
Time frame: One year
Determinants of Time in Therapeutic Range
Time frame: Patients will be followed for an expected mean time of 25 months
Use of digoxin in atrial fibrillation
Time frame: At baseline
Echocardiographic characteristics in patients with paroxysmal or persistent/permanent atrial fibrillation
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Results publication: PubMed 25288566Pignatelli P, Pastori D, Farcomeni A, Nocella C, Bartimoccia S, Vicario T, Bucci T, Carnevale R, Violi F. Mediterranean diet reduces thromboxane A2 production in atrial fibrillation patients. Clin Nutr. 2015 Oct;34(5):899-903. doi: 10.1016/j.clnu.2014.09.011. Epub 2014 Sep 28.
- Results publication: PubMed 25392853Pignatelli P, Pastori D, Carnevale R, Farcomeni A, Cangemi R, Nocella C, Bartimoccia S, Vicario T, Saliola M, Lip GY, Violi F. Serum NOX2 and urinary isoprostanes predict vascular events in patients with atrial fibrillation. Thromb Haemost. 2015 Mar;113(3):617-24. doi: 10.1160/TH14-07-0571. Epub 2014 Nov 13.
- Results publication: PubMed 25429521Pastori D, Pignatelli P, Angelico F, Farcomeni A, Del Ben M, Vicario T, Bucci T, Raparelli V, Cangemi R, Tanzilli G, Lip GYH, Violi F. Incidence of myocardial infarction and vascular death in elderly patients with atrial fibrillation taking anticoagulants: relation to atherosclerotic risk factors. Chest. 2015 Jun;147(6):1644-1650. doi: 10.1378/chest.14-2414.
- Results publication: PubMed 25460369Pastori D, Farcomeni A, Bucci T, Cangemi R, Ciacci P, Vicario T, Violi F, Pignatelli P. Digoxin treatment is associated with increased total and cardiovascular mortality in anticoagulated patients with atrial fibrillation. Int J Cardiol. 2015 Feb 1;180:1-5. doi: 10.1016/j.ijcard.2014.11.112. Epub 2014 Nov 18.
- Results publication: PubMed 25825798Pastori D, Carnevale R, Bartimoccia S, Nocella C, Tanzilli G, Cangemi R, Vicario T, Catena M, Violi F, Pignatelli P. Does Mediterranean Diet Reduce Cardiovascular Events and Oxidative Stress in Atrial Fibrillation? Antioxid Redox Signal. 2015 Sep 10;23(8):682-7. doi: 10.1089/ars.2015.6326. Epub 2015 Apr 28.
- Results publication: PubMed 25995397Pignatelli P, Pastori D, Vicario T, Bucci T, Del Ben M, Russo R, Tanzilli A, Nardoni ML, Bartimoccia S, Nocella C, Ferro D, Saliola M, Cangemi R, Lip GY, Violi F. Relationship between Mediterranean diet and time in therapeutic range in atrial fibrillation patients taking vitamin K antagonists. Europace. 2015 Aug;17(8):1223-8. doi: 10.1093/europace/euv127. Epub 2015 May 19.
- Results publication: PubMed 26318513Pastori D, Pignatelli P, Saliola M, Carnevale R, Vicario T, Del Ben M, Cangemi R, Barilla F, Lip GY, Violi F. Inadequate anticoagulation by Vitamin K Antagonists is associated with Major Adverse Cardiovascular Events in patients with atrial fibrillation. Int J Cardiol. 2015 Dec 15;201:513-6. doi: 10.1016/j.ijcard.2015.08.054. Epub 2015 Aug 5.
- Results publication: PubMed 26385032Pastori D, Pignatelli P, Farcomeni A, Cangemi R, Hiatt WR, Bartimoccia S, Nocella C, Vicario T, Bucci T, Carnevale R, Lip GY, Violi F. Urinary 11-dehydro-thromboxane B2 is associated with cardiovascular events and mortality in patients with atrial fibrillation. Am Heart J. 2015 Sep;170(3):490-7.e1. doi: 10.1016/j.ahj.2015.05.011. Epub 2015 May 22.
- Results publication: PubMed 26471883Pastori D, Farcomeni A, Poli D, Antonucci E, Angelico F, Del Ben M, Cangemi R, Tanzilli G, Lip GY, Pignatelli P, Violi F. Cardiovascular risk stratification in patients with non-valvular atrial fibrillation: the 2MACE score. Intern Emerg Med. 2016 Mar;11(2):199-204. doi: 10.1007/s11739-015-1326-1. Epub 2015 Oct 15.
- Results publication: PubMed 27565838Pastori D, Pignatelli P, Perticone F, Sciacqua A, Carnevale R, Farcomeni A, Basili S, Corazza GR, Davi G, Lip GYH, Violi F; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) study group. Aspirin and renal insufficiency progression in patients with atrial fibrillation and chronic kidney disease. Int J Cardiol. 2016 Nov 15;223:619-624. doi: 10.1016/j.ijcard.2016.08.224. Epub 2016 Aug 14.
- Results publication: PubMed 27609361Pastori D, Pignatelli P, Farcomeni A, Menichelli D, Nocella C, Carnevale R, Violi F. Aging-Related Decline of Glutathione Peroxidase 3 and Risk of Cardiovascular Events in Patients With Atrial Fibrillation. J Am Heart Assoc. 2016 Sep 8;5(9):e003682. doi: 10.1161/JAHA.116.003682.
- Results publication: PubMed 27270651Pastori D, Pignatelli P, Farcomeni A, Nocella C, Bartimoccia S, Carnevale R, Violi F. Age-related increase of thromboxane B2 and risk of cardiovascular disease in atrial fibrillation. Oncotarget. 2016 Jun 28;7(26):39143-39147. doi: 10.18632/oncotarget.9826.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Atrial Fibrillation (AF)
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto I Policlinico di Roma, Sapienza Università di Roma
Rome, Italy
Francesco Violi, Prof study director
Sapienza Università di Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Metabolic Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of metabolic syndrome in anticoagulated nonvalvular atrial fibrillation patients (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01882114, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.