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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 May 2021 |
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Main ID: |
NCT03085576 |
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Date of registration:
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05/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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NATional TUnisian REgistry of Atrial Fibrillation
NATURE-AF |
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Scientific title:
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National Tunisian Registry of Atrial Fibrillation |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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910 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03085576 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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Faouzi Addad, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least one episode of atrial fibrillation, documented on a 12-lead ECG and / or a
rhythmic holter (duration of the episode: 30 seconds or more)
- Recent atrial fibrillation diagnosed for less than a year
- Regular monitoring every 3 months is ensured
- Informed, read and signed consent
Exclusion Criteria:
- Estimated life expectancy at less than 12 months
- Transient atrial fibrillation due to reversible cause (eg acute myocardial infarction,
following cardiac surgery, acute alcohol intoxication, hyperthyroidism, pulmonary
embolism or other acute pulmonary disease, pericarditis, myocarditis,
hydro-electrolyte disorder, metabolic disorder)
- Cardiac surgery = 3 months
- Atrial flutter isolated without atrial fibrillation
- Mental disorders
- Ongoing anticoagulation for reasons other than atrial fibrillation
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Primary Outcome(s)
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Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death
[Time Frame: Every 3 months up to 1 year]
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Secondary Outcome(s)
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Measurement of INR (International Normalized Ratio)
[Time Frame: Every month for 1 year]
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Haemorrhagic accidents
[Time Frame: Every 3 months up to 1 year]
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TTR (percent Time in Therapeutic INR Range)
[Time Frame: 1 year]
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Secondary ID(s)
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DAC-001-NATUREAF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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