| CTRI Number |
CTRI/2018/07/015026 [Registered on: 24/07/2018] Trial Registered Prospectively |
| Last Modified On: |
23/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Biomarkers Estimation in Stroke |
|
Scientific Title of Study
|
Diagnostic evaluation of Plasma GFAP for the rapid differentiation between Ischemic Stroke and Intracerebral Hemorrhage |
| Trial Acronym |
BE FAST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeyaraj Durai Pandian |
| Designation |
Principal and Professor of Neurology |
| Affiliation |
Christian Medical College |
| Address |
Ground floor,
Department of Neurology,
Christian Medical College,
Brown Road,
Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeyaraj Durai Pandian |
| Designation |
Principal and Professor of Neurology |
| Affiliation |
Christian Medical College |
| Address |
Ground floor,
Department of Neurology,
Christian Medical College,
Brown Road,
Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeyaraj Durai Pandian |
| Designation |
Principal and Professor of Neurology |
| Affiliation |
Christian Medical College |
| Address |
Ground floor,
Department of Neurology,
Christian Medical College,
Brown Road,
Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurology
Johann Wolfgang Goethe – University
Schleusenweg 2-16
60528 Frankfurt am Main
Germany
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Brown Road,
Ludhiana 141008 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Johann Wolfgang Goethe University |
Schleusenweg 2-16
60528 Frankfurt am Main Germany
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeyaraj Durai Pandian |
Christian Medical College, |
Ground Floor, Department of Neurology,
Christian Medical College,
Brown Road,
Ludhiana -141008
Ludhiana
PUNJAB |
9915784750
jeyarajpandian@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Having neurological symptoms at hospital admission suspicious for acute stroke , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of neurological symptoms at hospital admission suspicious for acute stroke
2. Time interval from symptom onset to study inclusion < 12 h
|
|
| ExclusionCriteria |
| Details |
1. Ischemic stroke, intracerebral hemorrhage or transient ischemic attack within the last three months
2. Patients participating in other stroke trials/research
3. Known history of brain tumor at any time in patient history
4. Evidence for traumatic brain injury with the last 3 months
5. Participant in another stroke study
6. Informed consent not given
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of GFAP for differentiating patients with ICH from patients with ischemic stroke (including TIA) and stroke mimics.
2. Gold standard is the diagnosis of ICH, ischemic stroke (including TIA), or stroke mimic as determined at the end of hospital stay based on all available information.
|
1 month after the end of recruitment phase |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Analysis stratified for patients with a moderate to severe neurological deficit (NIHSS 9).
2. Analysis stratified for patients with different time windows (2 h, 2 to 6 h, 6 to 12 h) from symptom onset to blood withdrawal.
3. Correlation between GFAP values and ICH volume and location.
|
At the time of result analysis |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication of BE FAST I (2012) and BE FAST II (2017)
1. Foerch C, Niessner M, Back T, Bauerle M, De Marchis GM, Ferbert A, Grehl H, Hamann GF, Jacobs A, Kastrup A, Klimpe S, Palm F, Thomalla G, Worthmann H, Sitzer M, Group BFS (2012) Diagnostic accuracy of plasma glial fibrillary acidic protein for differentiating intracerebral hemorrhage and cerebral ischemia in patients with symptoms of acute stroke. Clin Chem 58:237–245. doi: 10.1373/clinchem.2011.172676
2. Sebastian Luger, Jens Witsch, Andreas Dietz, Gerhard F. Hamann, Jens Minnerup, Hauke Schneider, Matthias Sitzer, Katja E. Wartenberg, Marion Niessner, Christian Foerch (2017) Glial Fibrillary Acidic Protein Serum Levels Distinguish between Intracerebral Hemorrhage and Cerebral Ischemia in the Early Phase of Stroke. Clinical Chemistry Jan 2017, 63 (1) 377-385 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Stroke is the second most common cause of death globally. To date, brain imaging is the gold standard for distinguishing patients with ischemic stroke and intracerebral hemorrhage, which requires hospital admittance of patients with symptoms suspicious for acute stroke and causes a tremendous time-to-treatment delay. A rapid and reliable diagnostic test to distinguish ischemic from hemorrhagic stroke is essential to optimize management and triage for thrombolytic therapy. Several studies conducted by Dr. Förch, a Neurologist in Germany, have shown that the brain-specific biomarker GFAP is released rapidly in acute ICH, whereas a more delayed release can be observed in patients with ischemic stroke. Now it is important to replicate these findings in other populations as well. Based on the higher incidence rates in Asia and potential racial differences in GFAP release between Asian and Caucasian populations, the diagnostic accuracy of the GFAP testing need to be re-evaluated in a study performed in Asian countries. This shall be done by testing the plasma concentration of GFAP of 200 patients admitted to CMC, Ludhiana with symptoms suspicious of acute stoke (targeting 80 patients with ICH and 120 patients with ischemic stroke or stroke mimics). |