Atrial FibrillationARAPACISNCT01161251
Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study.
An observational study of Atrial Fibrillation and Peripheral Vascular Disease, run by University of Roma La Sapienza at 2 sites in Italy.
Trial summary
Atrial fibrillation (AF) is the most common sustained dysrhythmia encountered in clinical practice in North America and Europe, accounting for approximately one-third of all hospitalizations for a cardiac rhythm abnormality. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Peripheral Vascular Disease
- How many people
- 2,027 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2010to Dec 2014
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators plan to include in the study n = 3,000 AF patients, with competitive recruitment between centers involved in the study. The sample size was calculated assuming an expected prevalence of 19% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 1.4%. This sample size yields a power greater than 99.9% for the secondary endpoint, assuming an event rate of 19% for patients with ABI <=0.9, and 10% for patients with ABI >0.9.An interim analysis showed an ABI prevalence, calculated by exact confidence intervals, of 21% in patients with AF, it is considered to interrupt the enrollment, as the observed prevalence is greater than two percentage points higher than that assumed. The sample size is amended as follows: a sample of 2,027 patients leads to the expected prevalence of 21% with a confidence interval width of 3.5. This sample size has no impact on the power of the secondary objective.
Who may be able to join
- Non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
- Genders Eligible for Study: Both
- Ages Eligible for Study 18 years and older
- Signed written informed consent
Who cannot join
- Valvular AF
- Cancer
- Disease with life expectancy less than 3 years
- Pregnancy
- Hyperthyroidism
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Sapienza - University of Rome and SIMI
Rome, Italy, 00161
Società Italiana di Medicina Interna
Rome, Rome, 00161
About this study
Atrial fibrillation (AF) is the most common sustained dysrhythmia encountered in clinical practice in North America and Europe, accounting for approximately one-third of all hospitalizations for a cardiac rhythm abnormality. The presence of AF markedly increases the patient's risk for developing arterial embolism and stroke, depending on the presence of other clinical conditions, such as hypertension and diabetes. AF is associated with a fivefold increased risk for stroke, and is estimated to cause 15% of all strokes.
Patients with AF frequently have several risk factors for atherosclerosis, including hypertension, diabetes, and dyslipidemia. Accordingly, systemic signs of atherosclerosis can be detected in AF patients, and these likely accounts for an enhanced risk of coronary heart disease. In addition to cerebrovascular disease, patients with AF may suffer from coronary events including myocardial infarction (MI), but the rate of MI in AF patients seems to be variable, but often underestimated.
Read more
Moreover, coexistence of peripheral arterial disease (PAD) is a relevant clinical sign of systemic atherosclerosis.
Ankle-brachial index (ABI) is a simple, inexpensive, and non-invasive PAD measurement, even at the pre-symptomatic phase when intervention can improve prognosis and prevent or delay severe complications ABI is calculated by measuring the systolic blood pressure in the posterior tibial and/or the dorsalis pedis arteries either in both legs or 1 leg chosen at random (using a Doppler probe or alternative pulse sensor), with the lowest ankle pressure then divided by the brachial systolic blood pressure. In addition to peripheral artery disease, the ABI also is an indicator of generalized atherosclerosis because lower levels have been associated with higher rates of concomitant coronary and cerebrovascular disease, and with the presence of cardiovascular risk factors.
Two large studies in patients with AF document the existence of PAD in about 3-5% of patients. It is possible, however, that such an incidence has been underestimated as only symptomatic patients were considered as affected by PAD. As PAD is an important marker of systemic atherosclerosis, its association with AF reinforces the concept that patients with AF have systemic atherosclerosis that potentially account for coronary complications.
To date, a national registry of AF patients is not available to verify the real impact of cardiovascular events in this clinical setting.
Read the detailed description
Study design: Prospective longitudinal study
Methods and Materials: The investigators planned to assess at baseline and at scheduled follow up visits :
- Ankle-Brachial Index measurement
- Anamnestic clinical information and Anthropometric measurements
- Echocardiogram (volume size), electrocardiogram (AF type)
- Outcome events such as nonfatal or fatal acute myocardial infarction, target lesion or vessel revascularization nonfatal or fatal ischemic stroke, transient ischemic attack, death from any cardiac or vascular cause, death from any cause Study duration: 3 years follow-up Statistical methods: The prevalence will be calculated by exact confidence intervals (Wilson method). The cumulative incidence will be calculated by the product-limit estimator of Kaplan-Meyer and presented with confidence intervals at 95%. The incidences and prevalences will be then adjusted through appropriate multivariate analysis (using the Cox proportional hazards model and logistic model) that will take into account the effect of potential confounders. Similarly, the effect-center presence will be checked and possibly removed. Secondary endpoints will be assessed by using Log-rank test method, and by the Cox model (with time-dependent effects) multivariate analysis.
Subgroups analysis will be also conducted for patients with first onset of AF or recurrent AF Sample size: The investigators plan to include in the study n = 3,000 AF patients, with competitive recruitment between centers involved in the study. The sample size was calculated assuming an expected prevalence of 19% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 1.4%. This sample size yields a power greater than 99.9% for the secondary endpoint, assuming an event rate of 19% for patients with ABI <=0.9, and 10% for patients with ABI >0.9.An interim analysis showed an ABI prevalence, calculated by exact confidence intervals, of 21% in patients with AF, it is considered to interrupt the enrollment, as the observed prevalence is greater than two percentage points higher than that assumed. The sample size is amended as follows: a sample of 2027 patients leads to the expected prevalence of 21% with a confidence interval width of 3.5. This sample size has no impact on the power of the secondary objective.
- Conditions
- Atrial Fibrillation, Peripheral Vascular Disease
- Keywords
- Atrial Fibrillation, ABI, PAD, Registry, Italian
- Medical subject headings
- Atrial Fibrillation, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation patients | Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABI PREVALENCE
To estimate peripheral artery disease prevalence (defined by an Ankle-brachial index <=0.9) in AF patients.
Measured: 1 year
Secondary outcomes (1)
Vascular Events
To Estimate ischemic cardiovascular and cerebro-vascular events (fatal or non-fatal ) incidence in AF patients with or without peripheral artery disease
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 2,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Violi, University of Roma La Sapienza
- Investigators
- Francesco Violi, Full Prof, Study chair, Prima Clinica Medica - Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161251
- Sponsor's protocol ID
- SIMI-ARA PACIS
- Acronym
- ARAPACIS
- Status last verified
- Feb 2015
- First submitted
- 12 Jul 2010
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Mannucci PM, Nobili A. Appropriateness of antithrombotic prophylaxis in the oldest old with non-valvular atrial fibrillation: ARAPACIS and REPOSI. Eur J Intern Med. 2015 Nov;26(9):e47-8. doi: 10.1016/j.ejim.2015.08.013. Epub 2015 Sep 5. No abstract available.
PubMed 26350113Pignatelli P, Pastori D, Perticone F, Corazza GR, Violi F; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) Study group. Lights and shadows in the management of old and new oral anticoagulants in the real world of atrial fibrillation by Italian internists. A survey from the Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study. Eur J Intern Med. 2015 Oct;26(8):e31-3. doi: 10.1016/j.ejim.2015.06.007. Epub 2015 Jun 27. No abstract available.
PubMed 26123820Violi F, Pastori D, Perticone F, Hiatt WR, Sciacqua A, Basili S, Proietti M, Corazza GR, Lip GY, Pignatelli P; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) STUDY group. Relationship between low Ankle-Brachial Index and rapid renal function decline in patients with atrial fibrillation: a prospective multicentre cohort study. BMJ Open. 2015 May 21;5(5):e008026. doi: 10.1136/bmjopen-2015-008026.
PubMed 25998039Violi F, Davi G, Proietti M, Pastori D, Hiatt WR, Corazza GR, Perticone F, Pignatelli P, Farcomeni A, Vestri AR, Lip GY, Basili S; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) STUDY Investigators. Ankle-Brachial Index and cardiovascular events in atrial fibrillation. The ARAPACIS Study. Thromb Haemost. 2016 Apr;115(4):856-63. doi: 10.1160/TH15-07-0612. Epub 2016 Jan 7.
PubMed 26740316Proietti M, Marra AM, Tassone EJ, De Vuono S, Corrao S, Gobbi P, Perticone F, Corazza GR, Basili S, Lip GY, Violi F, Raparelli V; ARAPACIS Study Investigators; GIS Group. Frequency of Left Ventricular Hypertrophy in Non-Valvular Atrial Fibrillation. Am J Cardiol. 2015 Sep 15;116(6):877-82. doi: 10.1016/j.amjcard.2015.05.060. Epub 2015 Jun 25.
PubMed 26183791Proietti M, Calvieri C, Malatino L, Signorelli S, Corazza GR, Perticone F, Vestri AR, Loffredo L, Davi G, Violi F, Basili S; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) STUDY Investigators. Relationship between carotid intima-media thickness and non valvular atrial fibrillation type. Atherosclerosis. 2015 Feb;238(2):350-5. doi: 10.1016/j.atherosclerosis.2014.12.022. Epub 2014 Dec 20.
PubMed 25555267Raparelli V, Proietti M, Butta C, Di Giosia P, Sirico D, Gobbi P, Corrao S, Davi G, Vestri AR, Perticone F, Corazza GR, Violi F, Basili S; ARAPACIS Study Investigators; GIS Group. Erratum to: medication prescription and adherence disparities in non valvular atrial fibrillation patients: an Italian portrait from the ARAPACIS study. Intern Emerg Med. 2015 Mar;10(2):261-5. doi: 10.1007/s11739-014-1166-4. No abstract available.
PubMed 25519853Raparelli V, Proietti M, Butta C, Di Giosia P, Sirico D, Gobbi P, Corrao S, Davi G, Vestri AR, Perticone F, Corazza GR, Violi F, Basili S. Medication prescription and adherence disparities in non valvular atrial fibrillation patients: an Italian portrait from the ARAPACIS study. Intern Emerg Med. 2014 Dec;9(8):861-70. doi: 10.1007/s11739-014-1096-1. Epub 2014 Jul 3.
PubMed 24990547Violi F, Davi G, Hiatt W, Lip GY, Corazza GR, Perticone F, Proietti M, Pignatelli P, Vestri AR, Basili S; ARAPACIS Study Investigators. Reply: ankle-brachial index in patients with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2014 Apr 15;63(14):1457-8. doi: 10.1016/j.jacc.2013.11.011. Epub 2013 Dec 4. No abstract available.
PubMed 24315905Violi F, Davi G, Hiatt W, Lip GY, Corazza GR, Perticone F, Proietti M, Pignatelli P, Vestri AR, Basili S; ARAPACIS Study Investigators. Prevalence of peripheral artery disease by abnormal ankle-brachial index in atrial fibrillation: implications for risk and therapy. J Am Coll Cardiol. 2013 Dec 10;62(23):2255-6. doi: 10.1016/j.jacc.2013.07.035. Epub 2013 Aug 14. No abstract available.
PubMed 23954332
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study.
- ClinicalTrials.gov ID
- NCT01161251
- Acronym / sponsor ID
- ARAPACIS / SIMI-ARA PACIS
- Conditions
- Atrial Fibrillation, Peripheral Vascular Disease
- Keywords
- Atrial Fibrillation, ABI, PAD, Registry, Italian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,027 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jul 2010 (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.
Atrial fibrillation (AF) is the most common sustained dysrhythmia encountered in clinical practice in North America and Europe, accounting for approximately one-third of all hospitalizations for a cardiac rhythm abnormality. The presence of AF markedly increases the patient's risk for developing arterial embolism and stroke, depending on the presence of other clinical conditions, such as hypertension and diabetes. AF is associated with a fivefold increased risk for stroke, and is estimated to cause 15% of all strokes.
Patients with AF frequently have several risk factors for atherosclerosis, including hypertension, diabetes, and dyslipidemia. Accordingly, systemic signs of atherosclerosis can be detected in AF patients, and these likely accounts for an enhanced risk of coronary heart disease. In addition to cerebrovascular disease, patients with AF may suffer from coronary events including myocardial infarction (MI), but the rate of MI in AF patients seems to be variable, but often underestimated.
Moreover, coexistence of peripheral arterial disease (PAD) is a relevant clinical sign of systemic atherosclerosis.
Ankle-brachial index (ABI) is a simple, inexpensive, and non-invasive PAD measurement, even at the pre-symptomatic phase when intervention can improve prognosis and prevent or delay severe complications ABI is calculated by measuring the systolic blood pressure in the posterior tibial and/or the dorsalis pedis arteries either in both legs or 1 leg chosen at random (using a Doppler probe or alternative pulse sensor), with the lowest ankle pressure then divided by the brachial systolic blood pressure. In addition to peripheral artery disease, the ABI also is an indicator of generalized atherosclerosis because lower levels have been associated with higher rates of concomitant coronary and cerebrovascular disease, and with the presence of cardiovascular risk factors.
Two large studies in patients with AF document the existence of PAD in about 3-5% of patients. It is possible, however, that such an incidence has been underestimated as only symptomatic patients were considered as affected by PAD. As PAD is an important marker of systemic atherosclerosis, its association with AF reinforces the concept that patients with AF have systemic atherosclerosis that potentially account for coronary complications.
To date, a national registry of AF patients is not available to verify the real impact of cardiovascular events in this clinical setting.
Detailed description
Study design: Prospective longitudinal study
Methods and Materials: The investigators planned to assess at baseline and at scheduled follow up visits :
- Ankle-Brachial Index measurement
- Anamnestic clinical information and Anthropometric measurements
- Echocardiogram (volume size), electrocardiogram (AF type)
- Outcome events such as nonfatal or fatal acute myocardial infarction, target lesion or vessel revascularization nonfatal or fatal ischemic stroke, transient ischemic attack, death from any cardiac or vascular cause, death from any cause Study duration: 3 years follow-up Statistical methods: The prevalence will be calculated by exact confidence intervals (Wilson method). The cumulative incidence will be calculated by the product-limit estimator of Kaplan-Meyer and presented with confidence intervals at 95%. The incidences and prevalences will be then adjusted through appropriate multivariate analysis (using the Cox proportional hazards model and logistic model) that will take into account the effect of potential confounders. Similarly, the effect-center presence will be checked and possibly removed. Secondary endpoints will be assessed by using Log-rank test method, and by the Cox model (with time-dependent effects) multivariate analysis.
Subgroups analysis will be also conducted for patients with first onset of AF or recurrent AF Sample size: The investigators plan to include in the study n = 3,000 AF patients, with competitive recruitment between centers involved in the study. The sample size was calculated assuming an expected prevalence of 19% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 1.4%. This sample size yields a power greater than 99.9% for the secondary endpoint, assuming an event rate of 19% for patients with ABI <=0.9, and 10% for patients with ABI >0.9.An interim analysis showed an ABI prevalence, calculated by exact confidence intervals, of 21% in patients with AF, it is considered to interrupt the enrollment, as the observed prevalence is greater than two percentage points higher than that assumed. The sample size is amended as follows: a sample of 2027 patients leads to the expected prevalence of 21% with a confidence interval width of 3.5. This sample size has no impact on the power of the secondary objective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation patients | – | –Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to include in the study n = 3,000 AF patients, with competitive recruitment between centers involved in the study. The sample size was calculated assuming an expected prevalence of 19% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 1.4%. This sample size yields a power greater than 99.9% for the secondary endpoint, assuming an event rate of 19% for patients with ABI <=0.9, and 10% for patients with ABI >0.9.An interim analysis showed an ABI prevalence, calculated by exact confidence intervals, of 21% in patients with AF, it is considered to interrupt the enrollment, as the observed prevalence is greater than two percentage points higher than that assumed. The sample size is amended as follows: a sample of 2,027 patients leads to the expected prevalence of 21% with a confidence interval width of 3.5. This sample size has no impact on the power of the secondary objective.
Key inclusion criteria (4 listed)
- Non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
- Genders Eligible for Study: Both
- Ages Eligible for Study 18 years and older
- Signed written informed consent
Key exclusion criteria (5 listed)
- Valvular AF
- Cancer
- Disease with life expectancy less than 3 years
- Pregnancy
- Hyperthyroidism
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
ABI PREVALENCE
Time frame: 1 year
To estimate peripheral artery disease prevalence (defined by an Ankle-brachial index <=0.9) in AF patients.
1 secondary outcome
Vascular Events
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Background: PubMed 26350113Mannucci PM, Nobili A. Appropriateness of antithrombotic prophylaxis in the oldest old with non-valvular atrial fibrillation: ARAPACIS and REPOSI. Eur J Intern Med. 2015 Nov;26(9):e47-8. doi: 10.1016/j.ejim.2015.08.013. Epub 2015 Sep 5. No abstract available.
- Background: PubMed 26123820Pignatelli P, Pastori D, Perticone F, Corazza GR, Violi F; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) Study group. Lights and shadows in the management of old and new oral anticoagulants in the real world of atrial fibrillation by Italian internists. A survey from the Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study. Eur J Intern Med. 2015 Oct;26(8):e31-3. doi: 10.1016/j.ejim.2015.06.007. Epub 2015 Jun 27. No abstract available.
- Background: PubMed 25998039Violi F, Pastori D, Perticone F, Hiatt WR, Sciacqua A, Basili S, Proietti M, Corazza GR, Lip GY, Pignatelli P; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) STUDY group. Relationship between low Ankle-Brachial Index and rapid renal function decline in patients with atrial fibrillation: a prospective multicentre cohort study. BMJ Open. 2015 May 21;5(5):e008026. doi: 10.1136/bmjopen-2015-008026.
- Results publication: PubMed 26740316Violi F, Davi G, Proietti M, Pastori D, Hiatt WR, Corazza GR, Perticone F, Pignatelli P, Farcomeni A, Vestri AR, Lip GY, Basili S; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) STUDY Investigators. Ankle-Brachial Index and cardiovascular events in atrial fibrillation. The ARAPACIS Study. Thromb Haemost. 2016 Apr;115(4):856-63. doi: 10.1160/TH15-07-0612. Epub 2016 Jan 7.
- Results publication: PubMed 26183791Proietti M, Marra AM, Tassone EJ, De Vuono S, Corrao S, Gobbi P, Perticone F, Corazza GR, Basili S, Lip GY, Violi F, Raparelli V; ARAPACIS Study Investigators; GIS Group. Frequency of Left Ventricular Hypertrophy in Non-Valvular Atrial Fibrillation. Am J Cardiol. 2015 Sep 15;116(6):877-82. doi: 10.1016/j.amjcard.2015.05.060. Epub 2015 Jun 25.
- Results publication: PubMed 25555267Proietti M, Calvieri C, Malatino L, Signorelli S, Corazza GR, Perticone F, Vestri AR, Loffredo L, Davi G, Violi F, Basili S; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) STUDY Investigators. Relationship between carotid intima-media thickness and non valvular atrial fibrillation type. Atherosclerosis. 2015 Feb;238(2):350-5. doi: 10.1016/j.atherosclerosis.2014.12.022. Epub 2014 Dec 20.
- Results publication: PubMed 25519853Raparelli V, Proietti M, Butta C, Di Giosia P, Sirico D, Gobbi P, Corrao S, Davi G, Vestri AR, Perticone F, Corazza GR, Violi F, Basili S; ARAPACIS Study Investigators; GIS Group. Erratum to: medication prescription and adherence disparities in non valvular atrial fibrillation patients: an Italian portrait from the ARAPACIS study. Intern Emerg Med. 2015 Mar;10(2):261-5. doi: 10.1007/s11739-014-1166-4. No abstract available.
- Results publication: PubMed 24990547Raparelli V, Proietti M, Butta C, Di Giosia P, Sirico D, Gobbi P, Corrao S, Davi G, Vestri AR, Perticone F, Corazza GR, Violi F, Basili S. Medication prescription and adherence disparities in non valvular atrial fibrillation patients: an Italian portrait from the ARAPACIS study. Intern Emerg Med. 2014 Dec;9(8):861-70. doi: 10.1007/s11739-014-1096-1. Epub 2014 Jul 3.
- Results publication: PubMed 24315905Violi F, Davi G, Hiatt W, Lip GY, Corazza GR, Perticone F, Proietti M, Pignatelli P, Vestri AR, Basili S; ARAPACIS Study Investigators. Reply: ankle-brachial index in patients with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2014 Apr 15;63(14):1457-8. doi: 10.1016/j.jacc.2013.11.011. Epub 2013 Dec 4. No abstract available.
- Results publication: PubMed 23954332Violi F, Davi G, Hiatt W, Lip GY, Corazza GR, Perticone F, Proietti M, Pignatelli P, Vestri AR, Basili S; ARAPACIS Study Investigators. Prevalence of peripheral artery disease by abnormal ankle-brachial index in atrial fibrillation: implications for risk and therapy. J Am Coll Cardiol. 2013 Dec 10;62(23):2255-6. doi: 10.1016/j.jacc.2013.07.035. Epub 2013 Aug 14. No abstract available.
- Società Italiana di Medicina InternaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Atrial Fibrillation (AF)
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.
Francesco Violi, Full Prof study chair
Prima Clinica Medica - Sapienza University of Rome
2 sites 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 Peripheral Vascular Disease, run by University of Roma La Sapienza at 2 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABI PREVALENCE (time frame: 1 year). 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 NCT01161251, which also lists 10 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 9 Mar 2016.