| CTRI Number |
CTRI/2024/06/069052 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to determine the risk factors and angiographic profile of young patients with acute coronary syndrome |
|
Scientific Title of Study
|
Evaluation of clinicoepidemiological profile and angiographic pattern in young patients with acute coronary syndrome : A prospective observational study |
| 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 Hargun Arneja |
| Designation |
Junior resident |
| Affiliation |
Dr. D Y Patil School of Medicine, Navi Mumbai |
| Address |
Department of General Medicine, Dr D Y Patil Hospital, 11, Ayyappa Temple Rd, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
7745016007 |
| Fax |
|
| Email |
drhargunarneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jadhav |
| Designation |
Associate Professor |
| Affiliation |
Dr. D Y Patil School of Medicine, Navi Mumbai |
| Address |
Department of General Medicine, Dr D Y Patil Hospital, 11, Ayyappa Temple Rd, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9833030030 |
| Fax |
|
| Email |
drpriyankabjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hargun Arneja |
| Designation |
Junior resident |
| Affiliation |
Dr. D Y Patil School of Medicine, Navi Mumbai |
| Address |
Department of General Medicine, Dr D Y Patil Hospital, 11, Ayyappa Temple Rd, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
7745016007 |
| Fax |
|
| Email |
drhargunarneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil Medical college and hospital, Nerul, Navi Mumbai - 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Hargun Arneja |
| Address |
Junior Resident, Department of General Medicine, Dr DY Patil medical college, Navi Mumbai - 400706 |
| 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 Hargun Arneja |
Dr DY Patil Hospital, Navi Mumbai |
CCU, 4th floor, Dr D Y Patil Hospital, Nerul, Navi Mumbai, Thane, Maharashtra 400706
Thane
MAHARASHTRA |
7745016007
drhargunarneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) for Biomedical and Health Research, Dr DY Patil medical college, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the criteria for ACS |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years of age or not willing to give consent to take part in study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study epidemiological and clinical profile of patients with Acute coronary syndrome in age less than 40 years |
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the outcome of young patients with ACS on the basis of risk factors, angiographic pattern and management. |
3 days |
|
|
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)
|
26/06/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
This is a prospective observational type of study of all cases diagnosed with Acute Coronary Syndrome admitted in cardiac critical care unit in our tertiary care hospital to evaluate the clinicoepidemiological profile and angiographic pattern in young patients with acute coronary syndrome. |