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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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