Biomarker-supported detection of paroxysmal atrial fibrillation in patients with cerebral ischemia.
| ISRCTN | ISRCTN46104198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46104198 |
| Secondary identifying numbers | Protocol 23/11/08 EC UMG |
- Submission date
- 04/01/2010
- Registration date
- 17/02/2010
- Last edited
- 23/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Raoul Stahrenberg
Scientific
Scientific
Department of Cardiology and Pneumology
University Hospital Goettingen
Robert-Koch-Str. 40
Goettingen
37075
Germany
| stahrenberg@med.uni-goettingen.de |
Study information
| Study design | Single centre observational longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | A longitudinal cohort study in patients presenting with acute cerebral ischemia to identify factors that are predictive individually or in combination for a diagnosis of atrial fibrillation during 12 months of follow-up. |
| Study acronym | Find-AF |
| Study objectives | Novel biomarkers will improve the diagnosis of paroxysmal atrial fibrillation in patients presenting with cerebral ischemia. |
| Ethics approval(s) | Approved by local ethics committee of the medical faculty of the university of Goettingen, Germany, on the 27th of January 2009 (ref: 23/11/08) |
| Health condition(s) or problem(s) studied | Cerebral ischemia, Atrial fibrillation |
| Intervention | Serial biomarker sampling for the identification of novel biomarkers to be used in the diagnosis of atrial fibrillation. Blood samples will be collected at 0, 6 and 12 hours after presentation. The primary marker will be the value of the change of natriuretic peptides over time after presentation, calculated as ratio N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at 0h / NT-proBNP at 24h. All patients will also undergo transthoracic echocardiography. 7-day Holter monitoring, 90-day telephone follow-up and 12 months clinical follow-up will be used to optimize detection of atrial fibrillation as the endpoint for which blood markers, clinical characteristics and echocardiographic markers may show prognostic value. |
| Intervention type | Other |
| Primary outcome measure | Diagnosis of atrial fibrillation from baseline up to 12 months follow-up |
| Secondary outcome measures | Major adverse cerebral or cardiovascular events (MACCE) |
| Overall study start date | 01/03/2009 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 included |
| Total final enrolment | 211 |
| Key inclusion criteria | 1. Cerebral ischemia, i.e. transient ischemic attack (TIA) or stroke 2. Ability and willingness to consent 3. Age > 18 years |
| Key exclusion criteria | 1. Inability or unwillingness to consent 2. Age < 18 years 3. Cerebral haemorrhage |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Cardiology and Pneumology
Goettingen
37075
Germany
37075
Germany
Sponsor information
University Hospital Goettingen (Germany) - Department of Cardiology and Pneumology
Hospital/treatment centre
Hospital/treatment centre
Robert-Koch-Str. 40
Goettingen
37075
Germany
| wachter@med.uni-goettingen.de | |
| Website | http://www.herzzentrum-goettingen.de |
"ROR" |
https://ror.org/021ft0n22 |
Funders
Funder type
Hospital/treatment centre
University Hospital Goettingen (Germany) - Department of Cardiology and Pneumology
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2010 | Yes | No | |
| Results article | results | 28/06/2013 | Yes | No | |
| Results article | cost-effectiveness results | 01/12/2013 | Yes | No | |
| Results article | results | 01/11/2019 | 23/09/2019 | Yes | No |
Editorial Notes
23/09/2019: Publication reference and total final enrolment number added.
