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临床试验/NCT06674304
NCT06674304进行中(未招募)不适用

Registry Initiative Across Borders for Atrial Fibrillation in Africa

Mohammed VI University Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3,000
试验地点
1
主要终点
Arial fibrillation complications under treatment

研究概览

简要总结

Atrial fibrillation is a penalizing disease in several ways: morbidity and mortality, health costs. Several multicenter registries have been published. Until now, no multicenter registry involving several countries has been carried out in Africa. The goal of RIBAT AF Africa is to fill this gap, by recruting patients from twelve african centers. All the centers are a third level Atrial Fibrillation managment facility centers.

After recruitment , a complete clinical assessment with analysis of comorbidities will be a priority of this registry to try to understand the epidemiological profile of atrial fibrillation in Africa. Then, we will proceed to the temporal classification of atrial fibrillation according to the 2024 ESC recommendations (type and thromboembolic risk in particular.).

After this step, the management will be analyzed with three main axes: management of comorbidities, antithrombotic treatment, rhythm and frequency control. Some therapeutic techniques such as ablation of atrial fibrillation were discussed without much detail because many countries do not yet have access to these expensive techniques.

A six-month evaluation is necessary to judge above all the applicability of the measures accessible in all countries and in particular anticoagulant treatment.

All these data will be recorded anonymously and electronically. Each country can have access to its own data anytime. The statistical analysis will be carried out by a team within the University Hospital of Tangier , as well as all IT logistics. This team will also organize electronic monitoring and underlying all abnomalities in CRF.

详细描述

I. Rational

Atrial fibrillation is a penalizing disease in several ways: morbidity and mortality, health costs. Several multicenter registries have been published. Until now, no multicenter registry involving several countries has been carried out. The goal of RIBAT AF Africa is to fill this gap.

II. Study objectives

  • To understand the epidemiological profile of atrial fibrillation in Africa,
  • to describe the management of atrial fibrillation in Morocco
  • to proceed to the temporal classification of atrial fibrillation according to the 2024 ESC recommendations (type and thromboembolic risk in particular.),
  • to analyze and describe the management of comorbidities,
  • to describe the antithrombotic treatment,
  • to study the association between heart failure with preserved ejection fraction and FA
  • to analyze the rhythm and frequency control.
  • to describe the imaging features in FA

III. Study timeline

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 18 years old
  • Patients with a documented history of AF for any length of time before enrolment or AF first diagnosed at enrolment visit/hospitalization
  • Patients previously diagnosed with AF must have at least one documented visit or hospitalization for AF (or AF-related complications) within the last 12 months before enrolment

排除标准

  • No formal diagnosis of AF in medical records
  • Only atrial flutter or other atrial tachycardia diagnosed
  • Participation in a clinical trial (but participation in another registry is allowed)

结局指标

主要结局

Arial fibrillation complications under treatment

时间窗: Six month follow up

After inclusion, the investigators carry out a six-month follow-up for the patients. During this prospective follow-up period, the primary judgment criterion that must be documented by the investigators is the occurrence of a complication linked to AF or its medical management. The main complications to be looked for are : 1. Death 2. Non fatal stroke or systemic embolic event 3. Non fatal haemorrhagic event 4. Drug side effects

次要结局

未报告次要终点

研究者

发起方
Mohammed VI University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

RAISSUNI Zainab

Professor of cardiology

Mohammed VI University Hospital

研究点 (1)

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