| CTRI Number |
CTRI/2023/05/053159 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
01/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between stroke and diabetic patients |
|
Scientific Title of Study
|
Association between stroke and diabetic retinopathy: An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siladitya Dewasi |
| Designation |
Resident MD Emergency Medicine |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Khaja Anwar berh, po-sripally, dist- Purba Barddhaman
Barddhaman
WEST BENGAL
713103
India |
| Phone |
9475539260 |
| Fax |
|
| Email |
siladityambbs12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarbari swaika |
| Designation |
Professor and HOD, Emergency Medicine |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
SSKM Hospital Rd, Bhowanipore, Kolkata, West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
8420405962 |
| Fax |
|
| Email |
dr.s.swaika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siladitya Dewasi |
| Designation |
Resident MD Emergency Medicine |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Khaja Anwar berh, po-sripally, dist- Purba Barddhaman
Barddhaman
WEST BENGAL
713103
India |
| Phone |
9475539260 |
| Fax |
|
| Email |
siladityambbs12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM Hospital |
| Address |
SSKM Hospital Rd, Bhowanipore, Kolkata, West Bengal 700020 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Siladitya Dewasi |
IPGME&R and SSKM Hospital |
SSKM Hospital Rd, Bhowanipore, Kolkata, West Bengal 700020
Kolkata
WEST BENGAL |
9475539260
siladityambbs12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I698||Sequelae of other cerebrovasculardiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
I)Diagnosed case of Type-1 and Type-2 Diabetes mellitus
II) Newly detected patients with diabetes diagnosed with FBS ≥126mg/dl or PPBS
≥200mg/dl or HBA1C ≥6.5 or RBS ≥200mg/dl with symptoms. (According to
American Diabetes Association)
III) Ischemic or Hemorrhagic Stroke old and newly diagnosed. |
|
| ExclusionCriteria |
| Details |
i. Retinopathy due to other possible causes (i.e Trauma, Acute Pancreatitis,
SLE, Hypertension etc)
ii. Patient with organ failure (i.e Chronic kidney disease Grade III onwards,
Decompensated Liver disease etc) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence of Diabetic Retinopathy in stroke patients |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="328"
Sample Size from India="328"
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)
|
01/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Stroke, which is the second leading cause of death among world’s population according to epidemiological research, especially in low-income and middle-income countries, where the number of stroke patients is increasing by about 2 million per year due to the aging of the population and the growth of the population base. To overcome this crucial situation, the assessment of risk factors and the related management for stroke is becoming the one of the most important directions of current treatment. It is known that diabetes is an important risk factor for stroke, and the incidence of stroke is 2 to 4 times more in people with diabetes than in those without diabetes. Worldwide, stroke constitutes a major health and societal burden for patients and their families. Given limited therapeutic options, effective preventive strategies and methods for early diagnosis are needed. |