| CTRI Number |
CTRI/2025/11/097779 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study Of Clinical profile Of Different Types Of Arrhythmias In Patients Presenting With heart attack. |
|
Scientific Title of Study
|
A Study Of Clinical profile Of Different Types Of Arrhythmias In Patients Presenting With Acute ST Elevation Myocardial Infarction In A Tertiary Care Centre. |
| 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 Shish mansuri |
| Designation |
Resident |
| Affiliation |
padmashree Dr DY patil University |
| Address |
Department of General Medicine, DY patil medical college, 11, Ayyappa temple road, Dr DY patil vidyanagar, sector 7, nerul, Navi mumbai, Thane.
f wing 503, palm beach residency, nerul ,navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
919925238868 |
| Fax |
|
| Email |
shishmansuri02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Bhate |
| Designation |
Professor |
| Affiliation |
padmashree Dr DY patil University |
| Address |
Department of General Medicine, DY patil medical college, 11, Ayyappa temple road, Dr DY patil vidyanagar, sector 7, nerul, Navi mumbai, Thane.
Department of General Medicine, DY patil medical college, 11, Ayyappa temple road, Dr DY patil vidyanagar, sector 7, nerul, Navi mumbai, Thane.
Thane
MAHARASHTRA
400706
India |
| Phone |
919821366812 |
| Fax |
|
| Email |
archbhate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Bhate |
| Designation |
Professor |
| Affiliation |
padmashree Dr DY patil University |
| Address |
Department of General Medicine, DY patil medical college, 11, Ayyappa temple road, Dr DY patil vidyanagar, sector 7, nerul, Navi mumbai, Thane.
Thane
MAHARASHTRA
400706
India |
| Phone |
919821366812 |
| Fax |
|
| Email |
archbhate@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shish mansuri |
| Address |
Resident in Department of General Medicine, DY patil medical college, 11, Ayyappa temple road, Dr DY patil vidyanagar, sector 7, nerul, Navi mumbai, thane, maharastra india 400706 |
| Type of Sponsor |
Other [not applicable] |
|
|
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 Shish Mansuri |
D.YPatil Hospital nerul |
Emergency room Cardiac ICU Medicine ICU And wards Cardiology General medicine
Thane
MAHARASHTRA |
919925238868
shishmansuri02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee (ICE) for Biomedical and Health research, Dr DY patil medical college, navigator mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I238||Other current complications following acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Acute ST elevation Myocardial Infarction with positive cardiac enzymes and ECG changes.
Patients who develop arrhythmias before during or after the treatment of STEMI presenting to the hospital.
Age more than 18 years.
|
|
| ExclusionCriteria |
| Details |
Dyselectrolytemias likeHyperkalemia Hypokalemia, Hypermagnesemia hypomagnesemia hypercalcemia hypocalcemia
Patients in metabolic or respiratory acidosis or alkalosis
Patients with structural heart disease.
Patients with valvular heart disease.
Pregnant females.
Non consenting patients.
Patients with renal and liver disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study clinical profile and different types of arrhythmias in patients presenting with acute ST-Elevation myocardial infarction |
baseline one and half years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study and classify arrhythmias in patients with acute ST elevation Myocardial infarction.
To study the outcome of patients undergoing the treatment for arrhythmias related to acute ST elevation Myocardial infarction, and the percentage of mortality related to such arrhythmias |
baseline one and half years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2025 |
| 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)
|
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
|
It is an observational study Clinico etiopathological study of clinical Profile of different types of arrhythmias that is problem in the electrical activity of the heart due to heart attack. In Patients Presenting With Acute ST Elevation Myocardial Infarction that is heart attack In A Tertiary Care Centre and their outcomes and inter relationships. it will help us with knowing the timing and process of how different arrhythmias occur and how to prevent them. |