Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study.

Atrial Fibrillation Clinical Trial

— ARAPACIS  

Official title:

Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161251
• Other study ID #: SIMI-ARA PACIS
• Status: Completed
• Phase: N/A
• First received: July 12, 2010
• Last updated: March 8, 2016
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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. 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.

Description:

Study design: Prospective longitudinal study

Methods and Materials: The investigators planned to assess at baseline and at scheduled follow up visits :

1. Ankle-Brachial Index measurement

2. Anamnestic clinical information and Anthropometric measurements

3. Echocardiogram (volume size), electrocardiogram (AF type)

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2027
• Est. completion date: December 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Valvular AF

• Cancer

• Disease with life expectancy less than 3 years

• Pregnancy

• Hyperthyroidism

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Locations

Country	Name	City	State
Italy	Sapienza - University of Rome and SIMI	Rome
Italy	Società Italiana di Medicina Interna	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

Pignatelli 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. — View Citation

Proietti M, Calvieri C, Malatino L, Signorelli S, Corazza GR, Perticone F, Vestri AR, Loffredo L, Davì G, Violi F, Basili S; ARAPACIS (Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study) STUDY Investiga — View Citation

Proietti 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 — View Citation

Raparelli V, Proietti M, Buttà C, Di Giosia P, Sirico D, Gobbi P, Corrao S, Davì 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 — View Citation

Raparelli V, Proietti M, Buttà C, Di Giosia P, Sirico D, Gobbi P, Corrao S, Davì 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 valvul — View Citation

Violi F, Daví 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 — View Citation

Violi F, Davì 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):145 — View Citation

Violi F, Davì 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 Inv — View Citation

Violi 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABI PREVALENCE	To estimate peripheral artery disease prevalence (defined by an Ankle-brachial index <=0.9) in AF patients.	1 year	No
Secondary	Vascular Events	To Estimate ischemic cardiovascular and cerebro-vascular events (fatal or non-fatal ) incidence in AF patients with or without peripheral artery disease	3 years	No

External Links

•   Società Italiana di Medicina Interna