Project REAL FIB: atrial fibrillation in real Praxis register
| ISRCTN | ISRCTN33778999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33778999 |
| Secondary identifying numbers | 2009, protocol version 6.0, 18.01.2010 |
- Submission date
- 09/03/2010
- Registration date
- 06/04/2010
- Last edited
- 06/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robert Hatala
Scientific
Scientific
Národný ústav srdcových a cievnych chorôb
Pod Krásnou hôrkou 1
Bratislava 37
833 48
Slovakia
| hatala@nusch.sk |
Study information
| Study design | Multicentre non-interventional observational prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Project REAL FIB - atrial fibrillation in real Praxis register: a multicentre, non-interventional, observational and prospective study |
| Study acronym | REAL FIB |
| Study objectives | Charting of therapeutic methods indicated by medical doctors of different specialisations (cardiologists, internists) in prevention of atrial fibrillation from all over the country. |
| Ethics approval(s) | Multicentric Ethics Committee approved on the 21st December 2009 (ref: 108728/2009-11) |
| Health condition(s) or problem(s) studied | Atrial fibrillation (AF) |
| Intervention | This is a non-interventional study, all interventions will be performed according to common clinical Praxis in the management and follow up of patients with atrial fibrillation on treatment. Baseline visit: 1. Demographic data collection 2. Risk factors assessment: height, weight, age, patient history (hypertension, age when AF diagnosed, coronary disease, heart failure, New York Heart Association [NYHA] classification, systolic dysfunction, ejection fraction, diastolic dysfunction, sick sinus syndrome, cardiostimulator, implantable cardioverter-defibrillator [ICD], history of cardiovascular surgery, other heart diseases, mitral valve disease and type, diabetes mellitus), blood sugar level, dyslipidaemia, cholesterol level, low density lipoprotein [LDL]-cholesterol level, chronic renal insufficiency, creatinine, urea, ions, thyreopathy, body mass index [BMI], transient ischaemic attack [TIA]/cerebrovascular accident [CVA], alcohol abuse, family history for AF, CHADS score 3. AF characteristics 4. Treatment strategy (rhythm control, frequency control, thrombembolism prevention, other treatment) Follow up (6 months): 1. Basic data 2. Accidental events 3. Treatment strategy Follow up (12 months): 1. Basic data 2. Accidental events 3. Treatment strategy |
| Intervention type | Other |
| Primary outcome measure | 1. To assess clinical profile of patients with atrial fibrillation 2. To assess contemporary treatment modalities and its effectiveness 3. To observe occurence of cardiovascular events prospectively |
| Secondary outcome measures | 1. To analyse correlation between treatment modalities indicated by medical doctors of different specialisations (cardiologists, internists) in prevention of atrial fibrillation 2. To collect treatment safety data |
| Overall study start date | 01/02/2010 |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | All patients diagnosed with atrial fibrillation (any age, either sex) |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 30/04/2011 |
Locations
Countries of recruitment
- Slovakia
Study participating centre
Národný ústav srdcových a cievnych chorôb
Bratislava 37
833 48
Slovakia
833 48
Slovakia
Sponsor information
Masaryk University (Czech Republic)
University/education
University/education
c/o Doc. RNDr. Ladislav Duek, Ph.D.
Institute of Biostatistics and Analyses
Faculty of Medicine and the Faculty of Science
Kamenice 2
Brno-Bohunice
625 00
Czech Republic
| dusek@iba.muni.cz | |
| Website | http://www.muni.cz/ |
"ROR" |
https://ror.org/02j46qs45 |
Funders
Funder type
University/education
Masaryk University (Czech Republic) - Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
