| CTRI Number |
CTRI/2024/05/067570 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding heart disease risk in people with spinal cord injuries above 30 years of age. |
|
Scientific Title of Study
|
A descriptive study to assess the risk of cardiovascular diseases in Spinal Cord Injury patients above 30 years of age. |
| 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 Rushikesh Eknath Kalwaghe |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
4th floor, B wing, All India Institute of Physical Medicine and Rehabilitation, Haji Ali, K. Khadye Marg, Mahalaxmi, Mumbai.
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9226852547 |
| Fax |
|
| Email |
rushikeshkalwaghe.99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Goyal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Physical Medicine and Rehabilitation, Haji Ali, K. Khadye Marg, Mahalaxmi, Mumbai.
Mumbai
MAHARASHTRA
400034
India |
| Phone |
7045773329 |
| Fax |
|
| Email |
vinaygoyal80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Eknath Kalwaghe |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
4th floor, B wing, All India Institute of Physical Medicine and Rehabilitation, Haji Ali, K. Khadye Marg, Mahalaxmi, Mumbai.
Mumbai
MAHARASHTRA
400034
India |
| Phone |
09226852547 |
| Fax |
|
| Email |
rushikeshkalwaghe.99@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Physical Medicine and Rehabilitation, Haji Ali, K. Khadye Marg, Mahalaxmi, Mumbai, Maharashtra, India-400034. |
|
|
Primary Sponsor
|
| Name |
Dr Rushikesh Eknath Kalwaghe |
| Address |
4th floor, B wing, All India Institute of Physical Medicine and Rehabilitation, Haji Ali, K. Khadye Marg,Mahalaxmi,Mumbai, Maharashtra,India - 400034 |
| 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 Rushikesh Eknath Kalwaghe |
All India Institute of Physical Medicine and Rehabilitation |
Department of Physical Medicine and Rehabilitation, Haji Ali, K. Khadye Marg, Mahalaxmi, Mumbai, Maharashtra, India - 400034
Mumbai
MAHARASHTRA |
09226852547
rushikeshkalwaghe.99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S10-S19||Injuries to the neck, (2) ICD-10 Condition: S20-S29||Injuries to the thorax, (3) ICD-10 Condition: S30-S39||Injuries to the abdomen, lower back, lumbar spine, pelvis and external genitals, (4) ICD-10 Condition: G95||Other and unspecified diseases ofspinal cord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Person with spinal cord injury (traumatic and non-traumatic).
2. A person with spinal cord injury of both sexes.
3. Above 30 years of age.
4. Duration of spinal cord injury more than 6 months.
|
|
| ExclusionCriteria |
| Details |
1. Age below 30 years,
2. Traumatic brain injury,
3. Stroke history,
4. Pregnant women
5. Amputation
6. History of diabetes mellitus and/or hypertension before Spinal cord injury
•Duration less than 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Framingham Risk Score,
Spinal Cord Independence Measure,
Waist circumference. |
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine which factors are more common in spinal cord injury patients that increase the risk of cardiovascular diseases. |
At baseline. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/05/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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)
|
To assess the risk of cardiovascular disease occurring in persons with spinal cord injury. To determine which factors are more common in spinal cord injury patients that increase the risk of cardiovascular diseases. To find the correlation between Spinal Cord Independence Measures score and risk level as per Framingham risk score. |