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CTRI Number  CTRI/2025/01/079041 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive 
Study Design  Other 
Public Title of Study   Study of ECG changes to assess severity of Heart Attack. 
Scientific Title of Study   Study of QRS Duration and R/Q Ratio in the assessment of severity of Acute Myocardial Infartcion 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagar C Hiremath 
Designation  Postgraduate Student 
Affiliation  Ballari Medical College and Research Centre, Ballari 
Address  Department of General Medicine, Ballari Medical College and Research Centre, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9611602492  
Fax    
Email  sagarhiremath333@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Umamaheshwari S 
Designation  Associate Proffesor 
Affiliation  Ballari Medical College and Research Centre, Ballari 
Address  Department of General Medicine, Ballari Medical College and Research Centre, Ballari

Bellary
KARNATAKA
583104
India 
Phone  8277070611  
Fax    
Email  uma_sura@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Umamaheshwari S 
Designation  Associate Proffesor 
Affiliation  Ballari Medical College and Research Centre, Ballari 
Address  Department of General Medicine, Ballari Medical College and Research Centre, Ballari

Bellary
KARNATAKA
583104
India 
Phone  8277070611  
Fax    
Email  uma_sura@yahoo.in  
 
Source of Monetary or Material Support  
Department of General Medicine, Ballari Medical College and Research Centre, Ballari, Karnataka, India - 583104 
 
Primary Sponsor  
Name  Sagar C Hiremath 
Address  Department of General Medicine, Ballari Medical College and Research Centre, Ballari, Karnataka, India - 583104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Sagar C Hiremath  Medical College Hospital  Department of General Medicine, Ballari Medical College and Research Centre
Bellary
KARNATAKA 
9611602492

sagarhiremath333@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, VIMS BALLARI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I210||ST elevation (STEMI) myocardial infarction of anterior wall, (2) ICD-10 Condition: I211||ST elevation (STEMI) myocardial infarction of inferior wall,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients who are having chest pain or other angina equivalents with characterstic ST segment elevation 
 
ExclusionCriteria 
Details  Age less than 18 years, NSTEMI, Previous history of hemorrhagic stroke, Aortic dissection, Active Internal Bleeding, Bleeding Diathesis 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The duration QRS can be correlated with the severity of acute MI in the form of variables such as LVEF, incidence of arrhythmias, Akinesia/Hypokinesia, Ejection Fraction, Kilip classing.
2. The R/Q ratio can be correlated with the severity of acute MI in the form of variables such as LVEF, incidence of arrhythmias, Akinesia/Hypokinesia, Ejection Fraction, Kilip classing.
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. The effect of thrombolytic therapy can be correlated with QRS duration & R/Q ratio assessment.  Baseline 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   22/02/2025 
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="0"
Months="6"
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 study aims to assess the relationship between QRS duration and the R/Q ratio in predicting the severity and short-term prognosis of acute myocardial infarction (AMI). The objectives include correlating QRS duration and R/Q ratio with AMI severity, evaluating their utility in assessing thrombolytic therapy response, and comparing these markers in relation to clinical outcomes such as left ventricular ejection fraction (LVEF), arrhythmias, and Killip class.

The study will be conducted at the Department of General Medicine, VIMS, Ballari, involving confirmed STEMI patients over 18 years of age. Key exclusion criteria include NSTEMI, history of hemorrhagic stroke, aortic dissection, and bleeding disorders. Data will be collected through detailed clinical assessments, including ECG recordings (12-lead, V4R, V7-V9 as appropriate), 2D echocardiography, and baseline laboratory tests. ECGs will be taken on admission and at 60 minutes post-thrombolysis. QRS duration and R/Q ratios will be analyzed to assess their correlation with AMI severity.

The sample size, based on QRS duration estimation, is 75 patients, with simple random sampling employed. Statistical analysis will use SPSS software, with comparisons made using t-tests and chi-square tests. The primary outcomes will focus on the relationship between QRS duration, R/Q ratio, and AMI severity, while secondary outcomes will evaluate the impact of thrombolytic therapy on these markers. The study aims to provide insights into the prognostic value of these ECG parameters in AMI management, offering potential for better risk stratification and therapeutic decision-making.

 
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