- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01161251
Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study. (ARAPACIS)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Rome, Italie, 00161
- Sapienza - University of Rome and SIMI
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Rome, Italie, 00161
- Società Italiana di Medicina Interna
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Atrial fibrillation patients
Non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
ABI PREVALENCE
Délai: 1 year
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To estimate peripheral artery disease prevalence (defined by an Ankle-brachial index <=0.9) in AF patients.
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Vascular Events
Délai: 3 years
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To Estimate ischemic cardiovascular and cerebro-vascular events (fatal or non-fatal ) incidence in AF patients with or without peripheral artery disease
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3 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Francesco Violi, Full Prof, Prima Clinica Medica - Sapienza University of Rome
Publications et liens utiles
Publications générales
- Raparelli 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. Erratum In: Intern Emerg Med. 2015 Mar;10(2):261-5.
- 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.
- 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. No abstract available.
- 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.
- Violi 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.
- 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 Cardiol. 2015 Sep 15;116(6):877-82. doi: 10.1016/j.amjcard.2015.05.060. Epub 2015 Jun 25.
- Proietti 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.
- Raparelli 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.
- Violi 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.
- Violi 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.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
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Plan pour les données individuelles des participants (IPD)
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