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

8 mars 2016 mis à jour par: Francesco Violi, University of Roma La Sapienza

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

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

2027

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Rome, Italie, 00161
        • Sapienza - University of Rome and SIMI
      • Rome, Italie, 00161
        • Società Italiana di Medicina Interna

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Atrial fibrillation patients
Non-valvular atrial fibrillation (paroxysmal, persistent or permanent)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
ABI PREVALENCE
Délai: 1 year
To estimate peripheral artery disease prevalence (defined by an Ankle-brachial index <=0.9) in AF patients.
1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Vascular Events
Délai: 3 years
To Estimate ischemic cardiovascular and cerebro-vascular events (fatal or non-fatal ) incidence in AF patients with or without peripheral artery disease
3 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Francesco Violi, Full Prof, Prima Clinica Medica - Sapienza University of Rome

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2010

Achèvement primaire (Réel)

1 octobre 2012

Achèvement de l'étude (Réel)

1 décembre 2014

Dates d'inscription aux études

Première soumission

12 juillet 2010

Première soumission répondant aux critères de contrôle qualité

12 juillet 2010

Première publication (Estimation)

13 juillet 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

9 mars 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 mars 2016

Dernière vérification

1 février 2015

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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OUI

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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