| CTRI Number |
CTRI/2023/07/054778 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Platform Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Stroke & factors that affect outcome |
|
Scientific Title of Study
|
Prospective Global Platform to Evaluate & Enhance Cognitive and Functional Trajectories after Stroke |
| Trial Acronym |
PROSPECT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol version no. 4.0, dated January 10, 2023 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Denis Xavier |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Research Institute |
| Address |
Department of Pharmacology,
Head, Division of Clinical Research and Training,
St. Johns Medical College and Research Institute, St. Johns National
Academy of Health Sciences
Bangalore
KARNATAKA
560034
India |
| Phone |
08049466140 |
| Fax |
|
| Email |
denis.xavier@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atiya R Faruqui |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical College, St. Johns National Academy of Health Sciences |
| Address |
Department of Pharmacology
St Johns Medical College, St Johns National Academy of Health Sciences
Bangalore, KARNATAKA - 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9980018022 |
| Fax |
|
| Email |
atiya.rf@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa S |
| Designation |
Project Officer |
| Affiliation |
St. Johns Research Institute, St. Johns National Academy of Health Sciences |
| Address |
Division of Clinical Research and Training,
St. Johns Research Institute, St. Johns National Academy of Health Sciences
Bangalore
KARNATAKA
560034
India |
| Phone |
7708736328 |
| Fax |
|
| Email |
deepa.sn@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| Hamilton Health Sciences through its Population Health Research Institute Hamilton ON Canada
237 Barton Street East Hamilton ON L8L 2X2 Canada
|
|
|
Primary Sponsor
|
| Name |
Hamilton Health Sciences Population Health Research Institute |
| Address |
Hamilton ON Canada 237 Barton Street East Hamilton ON L8L 2X2
Canada
|
| Type of Sponsor |
Other [Academic Sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Brazil
Canada
Chile
India
Ireland
Mexico
Rwanda
Tanzania
Uganda
United Kingdom |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Nambiar |
Amrita Institute of Medical Sciences and Research Centre |
Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
Ernakulam
KERALA |
8921485541
dr.vivek.in@gmail.com |
| Dr Indira Menon |
Bangalore Baptist Hospital |
Bellary Road , Hebbal , Bangalore - 560024
Bangalore
KARNATAKA |
9901744844
indiramenon@hotmail.co.uk |
| Dr Sankar Prasad Gorthi |
Bharathi Vidyapeeth Deemed University |
Bharathi Vidyapeeth Bhavan , Lal Bahadur Shastri Road, Joshi Vada , Sadashiv Peth, Pune, Maharashtra - 411030
Pune
MAHARASHTRA |
8800233991
spgorthi@gmail.com |
| Dr Jeyaraj Durai Pandian |
Christian Medical College and Hospital Ludhiana |
Brown Road, CMC campus , Ludhiana, Punjab 141008
Ludhiana
PUNJAB |
9915784750
jeyrajpandian@hotmail.com |
| Dr Prabhakar A T |
Christian Medical College Vellore |
Ranipet campus, kilminnal village Ranipet, Tamil Nadu - 632002
Vellore
TAMIL NADU |
9486197550
atprabhakar@gmail.com |
| Dr Sulena |
GuruGobind Singh Hospital |
Department of Neurology, Punjab, Punjab 5600029
Faridkot
PUNJAB |
7087907025
sulenasingh@yahoo.co.in |
| Dr Normal Chandra Borah |
Guwahati Neurological Research Centre , Hospitals |
Zoo Road, Jonali, RG Baruah Road, Near SBI Bank, Guwahati, Assam 781024
Sonitpur
ASSAM |
0361-2227715
ncborah@usa.net |
| Dr Praveen Sharma |
King George Medical University |
Shah mina Road, Chowk, Lucknow, Uttarpradesh 226003
Lucknow
UTTAR PRADESH |
7388111289
pspgimer@gmail.com |
| Dr Sarojaar Arallikatte |
KLEs Dr. Prabhakar Kore Hospital & MRC |
B1/1 Staff Quarters, JNMC Campus, Nehru Nagar , Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
9448468474
sarojaao2002@yahoo.com |
| Dr Denis Xavier |
St. Johns Medical College and Research Institute, St. Johns National Academy of Health Sciences |
Department of Pharmacology St Johns Medical College and St
Johns Research Institute
Koramangala
Bangalore
KARNATAKA - 560034
Bangalore
KARNATAKA |
08049466140
denis.xavier@stjohns.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Bangalore Baptist Hospital Institutional Review Board |
Approved |
| Biomedical and Health Research, Institutional Ethics Committee, CMC & H. |
Approved |
| Ethics Committee Institute Of Neurological Sciences Trust |
Approved |
| IEC, Amrita Vishwa Vidyapeetham, Kochi |
Approved |
| Institutional Ethics Committee Bharathi Vidyapeeth Deemed University |
Approved |
| Institutional Ethics Committee Guru Gobind Singh Medical College and Hospital |
Approved |
| Institutional Ethics Committee Of KLE Academy Of Higher Education And Research |
Approved |
| Institutional Ethics Committee, St John’s Medical College & Hospital, Bangalore |
Approved |
| Institutional Review Board (IRB) office of research Christian Medical College Vellore, India |
Approved |
| King George’s Medical University ,U.P., Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, (2) ICD-10 Condition: I688||Other cerebrovascular disorders indiseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT Applicable - NOne |
NOT Applicable - NOne |
| Intervention |
NOT Applicable - NOne |
NOT Applicable - NOne |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Ischemic stroke or ICH
2. 18 years or older
3. Within 16 weeks of the index event
4. ‘Probable stroke’ (high clinical suspicion of stroke based on acute focal neurological deficits in fitting with a neurovascular territory lasting for more than 24 hours, but without imaging confirmation of stroke) OR ‘definite stroke’ (brain imaging confirmed stroke [CT or MRI]).
|
|
| ExclusionCriteria |
| Details |
1. Patients will be excluded if they are deemed by the investigators to be unlikely to adhere to study processes.
2. If they have a neurological condition (besides stroke) that is associated with cognitive or functional decline
3. An established diagnosis of pre-stroke dementia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognition
MOCA/t-MOCA
Oxford Cognitive Screen
Number symbol coding task
Function
SAGE
smRSq
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
QoL
Mortality
Recurrent stroke or MACE
New diagnosis of dementia
Other adverse events (falls/fractures, infections, cancer, seizures)
Aphasia, fatigue, depression, anxiety, apathy
Physical activity
Other (Social Support & Food intake)
|
At 6-month |
|
|
Target Sample Size
|
Total Sample Size="500"
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)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/12/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
PROSPECT, a prospective global registry for strokes will measure cognitive and functional impairment using validated and sensitive scales. This approach is pragmatic, patient-centered, and avoids the false dichotomy and regional variability of dementia diagnosis. PROSPECT will identify key determinants of cognitive and functional loss after stroke |