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CTRI Number  CTRI/2021/07/034862 [Registered on: 15/07/2021] Trial Registered Prospectively
Last Modified On: 29/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Clinical Profile of Myocardial Infarction  
Scientific Title of Study   Clinical And Angiographic Profile Of Acute Myocardial Infarction In Young Adults  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aineesh Vallurupalli 
Designation  Junior Resident 
Affiliation  Kasturba hospital manipal 
Address  room no 18 2nd floor general medicine department opd block Kasturba hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  9663974497  
Fax    
Email  aineeshv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vasudeva Acharya  
Designation  Professor 
Affiliation  kasturba hospital manipal 
Address  room no 19 2nd floor general medicine department opd block Kasturba hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  8197597008  
Fax    
Email  acharya.vasudev@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Aineesh Vallurupalli 
Designation  Junior Resident 
Affiliation  kasturba hospital manipal 
Address  room no 18 2nd floor general medicine department opd block Kasturba hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  9663974497  
Fax    
Email  aineeshv@gmail.com  
 
Source of Monetary or Material Support  
kasturba hospital manipal 
 
Primary Sponsor  
Name  Kasturba hospital manipal university  
Address  KMC Manipal Tiger Circle Road Madhav Nagar Manipal Karnataka 576104 
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 Vasudeva Acharya  Kasturba hospital manipal  room no 19 2nd floor general medicine department opd block Kasturba hospital manipal Tiger Circle Road, Madhav Nagar Manipal Karnataka 576104
Udupi
KARNATAKA 
8197597008

acharya.vasudev@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patient aged greater than 18 years of age or less than 45 years of age

Patients admitted to kasturba medical college and hospital manipal with a diagnosis of acute Myocardial infarction based on the WHO Criteria
 
 
ExclusionCriteria 
Details  Patients with age less than 18 years or greater than 45 years of age
Patient with a history of prior myocardial infarction or revascularisation
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To study clinical profile of Myocardial infarction in Young adults
To study etiological profile, angiographical profile and the outcome of myocardial infarction in the above population
 
To study clinical profile of Myocardial infarction in Young adults
To study etiological profile, angiographical profile and the outcome of myocardial infarction in the above population over 18 months
 
 
Secondary Outcome  
Outcome  TimePoints 
To study outcome of Myocardial infarction in Young adults
 
Patients will be included in the study as per inclusion and exclusion criteria after written and informed consent. Detailed clinical history and examination findings will be entered in predesigned proforma. As per standard protocol the patients will undergo ECG, Echocardiography laboratory investigations and angiography by the treating doctor and the data will be noted. The patient’s in-hospital course and outcome will be assessed
Patints will be assed during there course in the hospital  
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   23/07/2021 
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="1"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Previous studies have reported that there is a rising incidence of ACS in the young. The currently available evidence suggests young patients represent 0.4-19% of all ACS cases[4]

·      A significant proportion of the burden of coronary heart disease is attributed to behavioral or lifestyle factors including poor diet, obesity, and tobacco use. 

 

·      Biomedical risk factors such as hypercholesterolemia, hypertension, obesity, and diabetes are also known to contribute to the development of the disease.  [5]

 

·      In an analysis of age-standardized coronary heart disease (CHD) mortality in Canada over a 15-year period, South Asians had the highest CHD mortality compared with individuals of Chinese and European descent. [6]

 

·      South Asians where found to be prone to developing CHD at a younger age, often before the age of 45 years in men and are more likely to have significant left main, multi-vessel, and distal coronary artery disease.[6]

·      Consequences of MI can be devastating particularly at a young age due to its greater potential impact on the patient’s psychology, ability to work and the socioeconomic burden. As ‘‘young’’ MI patients may be the main income producer of the family, the aftermath of MI can also affect multiple dependents.

literature focussing on premature myocardial infarction (MI) in the young and focusing on the Indian population is lacking. Hence, it is important to identify the major risk factors and clinical profile of ACS in young adults so that future preventive measures can be taken in the form of lifestyle modification and pharmacotherapy

 

 
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