| CTRI Number |
CTRI/2019/09/021022 [Registered on: 02/09/2019] Trial Registered Prospectively |
| Last Modified On: |
28/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how ultrasound of the head can predict outcomes after an acute stroke |
|
Scientific Title of Study
|
Correlation between Pulsatility Index in Transcranial Doppler and Post Stroke Outcomes in patients with Acute Lacunar Strokes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Kumar P |
| Designation |
DM Neurology Resident |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology(SCTIMST) |
| Address |
Room No 1412, Department of Neurology,Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09488019581 |
| Fax |
|
| Email |
naveenkumal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajith Sukumaran |
| Designation |
Additional Professor and Guide |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology(SCTIMST) |
| Address |
Room No 3119(A), Department of Neurology,Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09495568035 |
| Fax |
|
| Email |
sajith.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajith Sukumaran |
| Designation |
Additional Professor and Guide |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology(SCTIMST) |
| Address |
Room No 3119(A), Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09495568035 |
| Fax |
|
| Email |
sajith.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunal Institute For Medical Sciences and Technology, Thiruvanathapuram, Kerala 695011 |
|
|
Primary Sponsor
|
| Name |
Dr Naveen Kumar P |
| Address |
Sree Chitra Institute For Medical Sciences and Technology, Thiruvananthapuram, Kerala 695011 |
| 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 |
| Dr Naveen Kumar P |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Room No 3110,Department of Neurology,Stroke services,Jai Nagat West road, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA |
09488019581
naveenkumal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCTIMST Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G465||Pure motor lacunar syndrome, (2) ICD-10 Condition: G466||Pure sensory lacunar syndrome, (3) ICD-10 Condition: G467||Other lacunar syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 80 years with acute or recent lacunar strokes (as per Trial of Organon Acute Stroke Treatment classification)
2. Evaluation within 2 weeks of stroke onset attending to Neurology, Stroke services, SCTIMST.
3. Imaging confirmation of acute lacunar stroke by MRI Brain.
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 or greater than 80 years.
2. Patients with evidence for large vessel atherosclerosis (greater than 50% stenosis of the extra or intracranial vessels with any of the imaging modalities)
3. Patients with large artery territory infarcts or major ICH at any point of time
4. Patients with prior psychiatric illness or cognitive impairment
5. Presence of heart failure, fever, respiratory distress or any other medical condition that can interfere with the neuropsychological assessment of the patient.
6. Impaired level of consciousness or significant aphasia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether changes in Pulsatility index in Transcranial Doppler correlates with post stroke outcome with respect to neurological deficits, disability and depression, following acute lacunar strokes |
0 and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective observational study to see how the presence and severity of deranged cerebral microvascular resistance (as indicated by the changes in Pulsatility Index in Transcranial Doppler) affects neuropsychological and functional recovery following acute lacunar strokes. Selected patients will be evaluated with Transcranial Doppler and baseline neurological deficits will be assessed by National Institute of Health Stroke Score(NIHSS), disability assessed by modified Rankin’s scale (mRS), and depression assessed by Beck’s depression Inventory-2 (BDI-2). These parameters will be reassessed at 3 months to see whether Pulsatility index at baseline can predict the functional and neuropsychological recovery following acute lacunar strokes. |