| CTRI Number |
CTRI/2024/11/076350 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ferritin levels in patients of acute ischaemic stroke |
|
Scientific Title of Study
|
Serum Ferritin level in patients with acute ischemic stroke and its role as a prognostic marker |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Kumar Gupta |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Third Floor
Department of General Medicine
Jawaharlal Nehru Medical College
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9713789666 |
| Fax |
|
| Email |
amangupta1907@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tushar Sontakke |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Medicine
Jawaharlal Nehru Medical College
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9713789666 |
| Fax |
|
| Email |
tushar.ihmp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aman Kumar Gupta |
| Designation |
Junior Resident |
| Affiliation |
JNMC, Wardha |
| Address |
Department of General Medicine
Jawaharlal Nehru Medical College
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9713789666 |
| Fax |
|
| Email |
amangupta1907@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institite of Higher Education and Research, Sawangi, Wardha, Maharashtra- 442001
India |
|
|
Primary Sponsor
|
| Name |
Dr Aman Kumar Gupta |
| Address |
Department of General Medicine, Datta Meghe Institute of Higher Education and Research
Sawangi, Wardha- 442001
Maharashtra
India |
| 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 Aman Kumar Gupta |
Jawaharlal Nehru Medical College |
Department of General Medicine
Jawaharlal Nehru Medical College
Sawangi Meghe
Wardha
Wardha
MAHARASHTRA |
9713789666
amangupta1907@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serum Ferritin levels |
Assessment of serum ferritin levels to analyse prognosis in patients with acute ischemic stroke |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Male and female are included |
|
| ExclusionCriteria |
| Details |
1. Patients presenting after 48-h of onset of symptoms of acute IS,
2. Patients with severe hepatic diseases, renal disease, or hematologic diseases,
3. Patients with previous stroke-related disability,
4. Patients with hepatic cancer,
5. Patients with no information on the functional outcome at 3 months after stroke,
6. Patients with transfusion of blood or blood components in last 7 days, and
7. Patients who recently received thrombolytic therapy. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Raised serum ferritin levels will indicate a poor prognosis of patients with acute ischaemic stroke |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of prognosis of stroke severity in relation with serum ferritin levels |
1 Month, 2 Months AND 3 MOnths |
|
|
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)
|
17/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amangupta1907@yahoo.com].
- For how long will this data be available start date provided 07-07-2023 and end date provided 12-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - -
|
|
Brief Summary
|
This research will be done prospectively in order to study and observe the relation between serum ferritin levels and its role in prognosis of acute ischemic stroke within a duration of 3 months at a teriary care hospital. In this study we will see if the prognosis of acute ischemic stroke with relation to serum ferritin . More is the serum ferritin level more will be the severity of stroke Grading will be done as per NIHSS Score |