CTRI Number |
CTRI/2022/12/048067 [Registered on: 13/12/2022] Trial Registered Prospectively |
Last Modified On: |
13/12/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Arrhythmias in Patients of Myocardial Infarction |
Scientific Title of Study
|
Arrhythmias in patients with ST elevation Myocardial infarction in first 48 hours – A cross-sectional study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR MALINI KULSHRESHTA |
Designation |
PROFESSOR |
Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Address |
ROOM NO 3039, DEPARTMENT OF MEDICINE, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , PHILIBIT BYPASS ROAD,SURESH SHARMA NAGAR,BAREILLY,U.P(243006)
Bareilly UTTAR PRADESH 243006 India |
Phone |
8218593127 |
Fax |
|
Email |
dr.malinik@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR MALINI KULSHRESHTA |
Designation |
PROFESSOR |
Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Address |
ROOM NO 3039, DEPARTMENT OF MEDICINE, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , PHILIBIT BYPASS ROAD,SURESH SHARMA NAGAR,BAREILLY,U.P(243006)
Bareilly UTTAR PRADESH 243006 India |
Phone |
8218593127 |
Fax |
|
Email |
dr.malinik@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR RAJAT AGGARWALA |
Designation |
PG RESIDENT |
Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Address |
ROOM NO 3035, DEPARTMENT OF MEDICINE, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , PHILIBIT BYPASS ROAD,SURESH SHARMA NAGAR,BAREILLY,U.P(243006)
Bareilly UTTAR PRADESH 243006 India |
Phone |
6280283728 |
Fax |
|
Email |
rajat191196@gmail.com |
|
Source of Monetary or Material Support
|
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , PHILIBIT BYPASS ROAD,SURESH SHARMA NAGAR,BAREILLY,U.P(243006) |
|
Primary Sponsor
|
Name |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Address |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , PHILIBIT BYPASS ROAD , SURESH SHARMA NAGAR , BARIELLY 243006 |
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 |
DR MALINI KULSHRESTHA |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF MEDICINE, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , PHILIBIT BYPASS ROAD , SURESH SHARMA NAGAR , BARIELLY , U.P (243006) Bareilly UTTAR PRADESH |
8218593127
dr.malinik@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC,RMCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Patients presenting within 48 hours of onset of symptoms suggestive of acute MI.
Patients with ECG changes suggestive of STEMI .
Acute MI patients with onset of arrythmia in 48 hours.
Patients with acute onset chest pain and TROP T positive within 48 hours of presentation
|
|
ExclusionCriteria |
Details |
Patients with past history of MI.
Patients with CAD on drugs.
Patients who are known cases of arrhythmias on
treatment.
Patients with structural defects in the heart
like Rheumatic Heart diseases and Congenital
Heart diseases.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To study incidence and profile of different types of recent onset arrhythmias in acute STEMI |
48 HOURS |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study various types of arrhythmias in co relation to the wall involved on ecg.
|
48 HOURS |
To study various types of arrhythmias in co relation to time between the admission and the onset. |
48 HOURS |
|
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)
|
19/12/2022 |
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
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Cardiovascular Disease (CVD) in India has become the common cause of mortality in all parts of India including Rural and the poorer states. As compared to the western population CVD affects Indian population a decade earlier. It is has been seen that deaths due to CVD in India by 2020 have increased by 2.1 folds compared to the year 1990 and this is higher than mortality rate predicted in any other region of the world. Acute Myocardial Infarction (AMI) is a clinical phase in the setting of myocardial ischemia with the evidence of myocardial injury . It is one of the commonest emergencies in the developed and developing countries. In the era prior to the use of fibrinolytic agents mortality due to acute MI was as high as 60 percent, which is more common within first twenty four hours, especially in the first hour. This high death rate was attributable to usually ventricular fibrillation. There are disease which precipitates the cardiac complication like Diabetes, Hypertension, Dyslipidaemia, Hyperthyroidism Amongst which diabetes is one of the main cause. In AMI, cardiac arrhythmias are well-recognised, frequent complications and important predictors of mortality, which can be due to an imbalance of autonomic nervous system and electrolytes and also due to ischemia which causes conduction blockade in the infarcted zone. Conduction abnormalities especially high grade atrio- ventricular block is a common complication of ST-Elevation Myocardial Infarction (STEMI) and although in the era of primary percutaneous coronary intervention, the rates of post-myocardial infarction and the incidence of conduction abnormalities is low and decreasing, but it continues to be associated major factor for in hospital deaths. Ventricular arrhythmias are common in the first 48 hours of infarction and continue to have a negative impact on the patient’s outcome . The magnitude of risk of arrhythmias in AMI varies from patient to patient, with infarct size and left ventricular function being the most important risk stratified. However in recent years, improvements in the diagnosis and treatment modalities has improved the outcomes associated with acute MI including the outcome of ventricular arrhythmias that occur following acute MI. These has led to significant fall in mortality associated with the complications of acute MI. With limited data available in various parts of India, This study is planned to evaluate the incidence of arrhythmias and its prognostic significance in peri infarct period. |