Condition category
Circulatory System
Date applied
04/01/2010
Date assigned
17/02/2010
Last edited
02/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raoul Stahrenberg

ORCID ID

Contact details

Department of Cardiology and Pneumology
University Hospital Goettingen
Robert-Koch-Str. 40
Goettingen
37075
Germany
stahrenberg@med.uni-goettingen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol 23/11/08 EC UMG

Study information

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.

Acronym

Find-AF

Study hypothesis

Novel biomarkers will improve the diagnosis of paroxysmal atrial fibrillation in patients presenting with cerebral ischemia.

Ethics approval

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)

Study design

Single centre observational longitudinal cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Diagnosis of atrial fibrillation from baseline up to 12 months follow-up

Secondary outcome measures

Major adverse cerebral or cardiovascular events (MACCE)

Overall trial start date

01/03/2009

Overall trial end date

28/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cerebral ischemia, i.e. transient ischemic attack (TIA) or stroke
2. Ability and willingness to consent
3. Age > 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300 included

Participant exclusion criteria

1. Inability or unwillingness to consent
2. Age < 18 years
3. Cerebral haemorrhage

Recruitment start date

01/03/2009

Recruitment end date

28/02/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Cardiology and Pneumology
Goettingen
37075
Germany

Sponsor information

Organisation

University Hospital Goettingen (Germany) - Department of Cardiology and Pneumology

Sponsor details

Robert-Koch-Str. 40
Goettingen
37075
Germany
wachter@med.uni-goettingen.de

Sponsor type

Hospital/treatment centre

Website

http://www.herzzentrum-goettingen.de

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Goettingen (Germany) - Department of Cardiology and Pneumology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20966415
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23840747
3. 2013 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/23904073

Publication citations

  1. Results

    Stahrenberg R, Weber-Krüger M, Seegers J, Edelmann F, Lahno R, Haase B, Mende M, Wohlfahrt J, Kermer P, Vollmann D, Hasenfuss G, Gröschel K, Wachter R, Enhanced detection of paroxysmal atrial fibrillation by early and prolonged continuous holter monitoring in patients with cerebral ischemia presenting in sinus rhythm., Stroke, 2010, 41, 12, 2884-2888, doi: 10.1161/STROKEAHA.110.591958.

  2. Results

    Weber-Krüger M, Gröschel K, Mende M, Seegers J, Lahno R, Haase B, Niehaus CF, Edelmann F, Hasenfuß G, Wachter R, Stahrenberg R, Excessive supraventricular ectopic activity is indicative of paroxysmal atrial fibrillation in patients with cerebral ischemia., PLoS ONE, 2013, 8, 6, e67602, doi: 10.1371/journal.pone.0067602.

  3. Mayer F, Stahrenberg R, Gröschel K, Mostardt S, Biermann J, Edelmann F, Liman J, Wasem J, Goehler A, Wachter R, Neumann A, Cost-effectiveness of 7-day-Holter monitoring alone or in combination with transthoracic echocardiography in patients with cerebral ischemia., Clin Res Cardiol, 2013, 102, 12, 875-884, doi: 10.1007/s00392-013-0601-2.

Additional files

Editorial Notes