| CTRI Number |
CTRI/2017/03/008214 [Registered on: 27/03/2017] Trial Registered Prospectively |
| Last Modified On: |
26/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine if patients with decreased blood supply in arteries of lower legs have increased risk of having reduced blood supply to the brain and suffering from Stroke |
|
Scientific Title of Study
|
Association between Ankle Brachial Index and Common Carotid Artery Intima Media Thickness in Patients with Ischemic Stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Hemant Kelkar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kelkarrohan91@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivashankar K N |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
shishamed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohan Hemant Kelkar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kelkarrohan91@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Rohan Hemant Kelkar |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Rohan Hemant Kelkar |
Kasturba Hospital, Manipal |
Department of General Medicine, Second Floor, New OPD Building, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9845488476
kelkarrohan91@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Manipal Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Ischaemic Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
An Observational Study to determine if an association exists between Ankle Brachial Index and Common Carotid Artery Intima Media Thickness in Patients with Ischemic Stroke |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Ischemic Stroke Patients more than or equal to 18 Years of Age |
|
| ExclusionCriteria |
| Details |
Patients with Hemorrhagic Stroke, Peripheral Vascular Disease Upper/Lower Limb Deformity Limb amputation Percutaneous or surgical revascularization of lower limb arteries or carotid arteries
Patients on therapy with Statins >1 year ABI > 1.4
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sigificant Association between Low Ankle Brachial Index and High Common Carotid Artery Intima Media Thickness in Patients with Ischemic Stroke |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Ankle Brachial Index in patients with Ischaemic Stroke |
2 years |
| Mean Common Carotid Artery Intima Media Thickness in patients with Ischaemic Stroke |
2 years |
|
|
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)
|
01/04/2017 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ankle Brachial Index (ABI) is an index used to diagnose presence of peripheral Vascular Disease. Common Carotid Intima Thickness (CIMT) has been widely used to assess the presence of atherosclerotic disease in the Carotid Arteries. Both Ischemic Stroke and Peripheral Vascular Disease involve Atherosclerotic Processes. ABI is quick, easy to perform investigation while measurement of CIMT requires sophisticated machinery and expertise.Primary purpose of Protocol- To study if an Association exists between Ankle Brachial Index and Common Carotid Artery Thickness in Patients with Ischemic Stroke.
Study Hypothesis - A Significant Assocation exists between Low Ankle Brachial Index and High Common Carotid Artery Intima Media Thickness in Patients with Ischemic Stroke A significant association between ABI and CIMT will enable the use of ABI as a screening method for identifying patients at risk for carotid atherosclerosis and ischemic stroke. |