| CTRI Number |
CTRI/2022/09/045676 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of clinical presentation of clinical syndromes associated with bleed or decreased blood supply to brain due to occlusion of arteries supplying hindbrain and brainstem. |
|
Scientific Title of Study
|
Clinical study of posterior circulation stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Bhat |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical college, Tiger circle road, Madhav Nagar, Manipal, Udupi district, karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9481618990 |
| Fax |
|
| Email |
vaibhavbhat919@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B A Shastry |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical college, Tiger circle road, Madhav Nagar, Manipal, Udupi district, karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9902252450 |
| Fax |
|
| Email |
shastryba@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhav Bhat |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical college, Tiger circle road, Madhav Nagar, Manipal, Udupi district, karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9481618990 |
| Fax |
|
| Email |
vaibhavbhat919@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vaibhav Bhat |
| Address |
Kasturba Medical college, Tiger circle road, Madhav Nagar, Manipal, Udupi district, karnataka |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vaibhav Bhat |
Kasturba Medical College |
Department of General Medicine Baliga Block, Tiger circle road, Madhav Nagar, Manipal, Udupi district, karnataka
Udupi
KARNATAKA |
9481618990
vaibhavbhat919@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G463||Brain stem stroke syndrome, (2) ICD-10 Condition: G464||Cerebellar stroke syndrome, (3) ICD-10 Condition: G462||Posterior cerebral artery syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than or equal to 18 years of age presenting with clinical features and radiological evidence of posterior circulation stroke. |
|
| ExclusionCriteria |
| Details |
(1.) Radiological evidence is present regarding haemorrhage or infarct in anterior circulation.
(2.) Radiological evidence of non-vascular lesion. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the clinical/ etiological profile in posterior circulation stroke. |
From date of admission to date of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Death |
From date of admission to date of death. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
26/09/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After
Obtaining instituitional Ethical committee clearance, patients will be included
after applying inclusion and exclusion criteria after written informed consent
is obtained. Detailed clinical history and examination findings will be entered
in predesigned proforma. Relevant data regarding clinical investigations will
be taken and recorded from the time of admission to discharge/ death. Using the
above, clinical profile/ etiological profile of patient’s of Posterior circulation
stroke will be determined. |