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CTRI Number  CTRI/2024/01/061723 [Registered on: 22/01/2024] Trial Registered Prospectively
Last Modified On: 21/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Occurrence and predictors of irregular heart rhythms and sudden cardiac death in the first 48hours after a heart attack  
Scientific Title of Study   Clinical profile of arrhythmias post acute myocardial infarction in the first 48hours 
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 Sreeja Gandamsetty 
Designation  Junior Resident, Department of Medicine  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal, Udupi KARNATAKA 576104 India.

Udupi
KARNATAKA
576104
India 
Phone  7382009444  
Fax    
Email  sreejagandhamsetty863@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ananthakrishna Shastry 
Designation  Professor and Head of unit, Medicine 13 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal, Udupi KARNATAKA 576104

Udupi
KARNATAKA
576104
India 
Phone  9845702450  
Fax    
Email  ba.shastry@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr T S Shashikala 
Designation  Assistant Professor, Department of General Medicine  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal, Udupi KARNATAKA 576104

Udupi
KARNATAKA
576104
India 
Phone  9441383024  
Fax    
Email  shashikala.ts@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Dr Sreeja Gandamsetty 
Address  Department of Medicine, Kasturba Medical College , Manipal, Udupi, Karnataka, 576104 
Type of Sponsor  Other [self] 
 
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 Sreeja Gandamsetty  Kasturba Medical College, Manipal  Department of Medicine, Kasturba medical college, Manipal, Udupi, Karnataka, India. 576104
Udupi
KARNATAKA 
7382009444

sreejagandhamsetty863@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital I Institutional Ethics Committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I21||Acute myocardial infarction,  
 
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 presenting with acute myocardial infarction above 18 years of age who can give written informed consent.
Acute myocardial infarction (MI) : Acute myocardial injury with clinical evidence of acute myocardial
ischemia and with detection of a rise and,or fall of cT values with at least one value above the 99th
percentile URL and at least one of the following:
1)Symptoms of myocardial ischemia
2)New ischemic electrocardiographic (ECG) changes
3) Development of pathologic Q waves
4)Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a
pattern consistent with an ischemic etiology 
 
ExclusionCriteria 
Details  1)Pregnant females
2)History of prior myocardial infarction or chronic heart failure
3)Patients already on anti arrhythmics or drugs prolonging QT interval
4)Patients with previously diagnosed structural and valvular heart diseases- cardiomyopathy, congenital heart
5)Patients with previously diagnosed channelopathies or conduction disorders
6)Patient on cardiac device therapy
7)Prior documented cardiac conduction abnormalities
8)Documented Active infection
9)Autoimmune diseases
10)Malignancy
11)Chronic obstructive pulmonary disease
12)Hypothyroidism
13)Hyperthyroidism
14)Documented Anemia
15)Patients on Beta blockers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between acute myocardial Infarction and arrhythmias in the first 48hours.  At the time of recruitment. 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze risk factors associated with increased occurrence of arrhythmias post acute MI
Evaluation of ECG indices associated with arrhythmias post acute MI in the first 48hours 
At the time of recruitment. 
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
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)   31/01/2024 
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="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  

Arrhythmias, may occur at any time of myocardial infarction, beginning  from the early minutes of acute infarction till the remote post-MI period.Although the incidence of VAs has declined in the hospital phase of acute coronary syndromes (ACS) mainly due to prompt revascularization and  early introduction of optimal medical therapy, the risk of cardiac arrest and sudden cardiac death (SCD) remains increased after MI and are predictors of worse in-hospital outcome in the setting of ACS.

Need for the study:

Risk factors if identified, helps in risk stratification, primary prevention and early intervention thereby reducing the morbidity and mortality associated with arrhythmias, which are a major cause of death in the early (<48hrs) post acute myocardial infarction period.

Description:

    A total of 196 participants will be recruited in the study after written informed consent ,using a preformed proforma, clinical, laboratory and imaging parameters will be collected from patients’ fitting the inclusion criteria. The parameters will be noted and relevant statistical analysis will be done to find correlation between acute myocardial Infarction and arrhythmias. The study will go on for 18months.

Detailed description of procedure / processes: After written informed consent ,using a preformed proforma, clinical, laboratory and imaging parameters will be collected from patients’ fitting the inclusion criteria.

1.Categorical variables will be expressed as frequency/percentage and will be compared using chi‐square test.

2.Continuous variables with normal distribution will be presented as mean ± standard deviation (SD)-compared using unpaired t test. Non‐normally distributed data will be expressed as median and interquartile range (IQR)-compared using Mann Whitney U test. 3.Multivariate logistic regression analysis will be performed to identify independent risk factors. A p‐value < 0.05 will be considered statistically significant for all tests.


 
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