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CTRI Number  CTRI/2021/07/034583 [Registered on: 05/07/2021] Trial Registered Prospectively
Last Modified On: 02/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessing if apo b levels correlate with the severity of myocardial infarction  
Scientific Title of Study   Correlation of levels of ApoB in type 2 diabetic patients presenting with first acute coronary event  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mukhilan Selvakumar C 
Designation  Junior resident 
Affiliation  MAnipal academy of higher Education  
Address  General medicine department, Room no,126, NIH B, Madhav nagar ,Manipal ,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9003877002  
Fax    
Email  mukhilan.c@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  DrMukhyaprana Prabhu 
Designation  Professor and HOU 
Affiliation  Manipal academy of higher education  
Address  General medicine department , Kasturba hospital ,Manipal ,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9449592986  
Fax    
Email  mm.prabhu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mukhilan Selvakumar C 
Designation  Junior resident 
Affiliation  Manipal academy of higher education 
Address  General medicine department, Room no,126, NIH B, Madhav nagar ,Manipal ,Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9003877002  
Fax    
Email  mukhilan.c@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba hospital, Manipal  
 
Primary Sponsor  
Name  Kasturba medical college Manipal 
Address  Tiger circle road , Madhav nagar , Manipal , Udupi ,Karnataka  
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 
Mukhilan Selvakumar C  Kasturba hospital, Manipal  Udupi-Hebri road , Madhav nagar, Manipal, Karnataka-576104
Udupi
KARNATAKA 		 9003877002

mukhilan.c@learner.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: I21||Acute myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  -Type 2 DM patients -First ACS event -Patients who have undergone coronary angiogram  
 
ExclusionCriteria 
Details  -Patients with current ACS event ,Type 1DM, Age less than 18 year -Patients with liver cirrhosis,CKD disease ,-viral infections like Hepatitis B,Hepatitis C or HIV, Hyperthyroidism, Familial hypercholesterolemia 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Correlation between severity of coronary artery disease and Apo B levels   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between apo and LDL levels   1 year 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2021 
Date of Study Completion (India) 30/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Diabetes Mellitus is a major risk factor for cardiovascular diseases and has been associated with 2-4 fold higher mortality. The risk estimation has for long been based on LDL but there is atherogenic dyslipidemia in diabetes which is characterised by low Hdl , elevated triglycerides and LDL . ApoB being present in very low density lipoproteins, intermediate density lipoprotein cholesterol and LDL cholesterol is a better indicator in the assessment of atherogenic dyslipidemia . 
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