| CTRI Number |
CTRI/2025/02/079868 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ECG changes after using clot dissolving agents after heart attack |
|
Scientific Title of Study
|
Study of ECG changes post thrombolysis in patients with acute STEMI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saloni Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General Medicine, Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9619069611 |
| Fax |
|
| Email |
Agarwal.saloni2704@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ND Moulick |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General Medicine, Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9833022282 |
| Fax |
|
| Email |
ndmoulick@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ND Moulick |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General Medicine, Dr DY Patil Medical College, Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
9833022282 |
| Fax |
|
| Email |
ndmoulick@rediff.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil Medical College and Hospital, Nerul, Navi Mumbai, Thane, Maharashtra, India- 400706 |
|
|
Primary Sponsor
|
| Name |
Saloni Agarwal |
| Address |
Junior Resident, Department of General Medicine, Dr DY Patil Medical College, Navi Mumbai-400706 |
| Type of Sponsor |
Other [Primary 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 Saloni Agarwal |
Dr DY Patil Medical college and Hospital, Navi Mumbai |
Department of General Medicine, Intensive care Unit, Dr DY Patil Medical college and Hospital, Navi Mumbai
Thane
MAHARASHTRA |
9619069611
agarwal.saloni2704@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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Thrombolysis |
Thrombolysis for STEMI by any thrombolysis agent (most commonly streptokinase for a duration of 1 hour and tenecteplase for a duration of 10 minutes) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with new onset ST elevated Myocardial infarction
Patients who have undergone thrombolysis for STEMI
Patients of both genders and above the age of 18 |
|
| ExclusionCriteria |
| Details |
Age less than 18, age more than 90.
Patients with past history of STEMI, PTCA, Thrombolysis for STEMI or CVA
Patients with contraindications for thrombolysis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ecg evaluation i.e. 50% reduction in largest ST segment elevation of reperfusion therapy (thrombolysis) in patients with STEMI. |
90 minutes post thrombolysis, 24 hours post thrombolysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of time taken for ECG changes to appear post thrombolysis- 50% reduction in largest ST segment elevation. |
90 minutes post thrombolysis, 24 hours post thrombolysios |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
12/02/2025 |
| 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 Yet Recruiting |
| 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 brief observational prospective study evaluation the ECG changes post thrombolysis in patients of STEMI, the time taken for such changes to occur and their correlation with other patient comorbidities and clinical presentation of patients |