| 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
|
|
|
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
|
|
|
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. |