| CTRI Number |
CTRI/2020/05/025122 [Registered on: 12/05/2020] Trial Registered Prospectively |
| Last Modified On: |
26/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate platelet indices as a marker in acute coronary syndrome and relation with other conditions like diabetes mellitu,dyslipidemia and inflammatory marker |
|
Scientific Title of Study
|
Platelet indices in acute coronary syndrome and relation with diabetes mellitus,dyslipidemia and inflammatory marker |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gokul Krishnan |
| Designation |
Junior resident,General Medicine |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine,Kasturba Hospital,Kasturba Medical College,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663597587 |
| Fax |
|
| Email |
gokulkrishnan8394@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gokul Krishnan |
| Designation |
Junior resident,General Medicine |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine,Kasturba Hospital,Kasturba Medical College,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663597587 |
| Fax |
|
| Email |
gokulkrishnan8394@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Mukhyaprana Prabhu |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical college,Manipal |
| Address |
Department of General Medicine
Kasturba Medical College,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9632118700 |
| Fax |
|
| Email |
mm.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Madhav nagar,Manipal,Udupi 576104,Karnataka,India |
| Type of Sponsor |
Private 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 |
| Gokul Krishnan |
Kasturba hospital |
Inpatients from all departments in all wards
Udupi
KARNATAKA |
9663597587
gokulkrishna8394@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21||Acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Those presenting with first episode of acute coronary syndrome |
|
| ExclusionCriteria |
| Details |
Platelet disorders(quantitative and qualitative)
Those on long term statins
Those on long term antiplatelet agents
Active infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess platelet indices among those presenting with acute coronary syndrome
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find relation between platelet indices and diabetes mellitus,dyslipidemia and inflammatory marker |
1 year |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
15/05/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aim is to find status of platelet indices among those presenting with acute coronary syndrome and to assess relation between platelet indices and diabetes mellitus,dyslpidemia and inflammatory marker
To analyse efficacy of platelet indices as a marker of acute coronary syndrome as it can be a cheaper alternative. |