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CTRI Number  CTRI/2025/10/096197 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Estimate the predictive role of serum SIRT-1 level and genetic association of PCSK9 gene with metabolic syndrome in patients of coronary artery disease 
Scientific Title of Study   Association of serum SIRT-1 level and PCSK9 gene polymorphism in coronary artery disease with metabolic syndrome 
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 Anwar Pervez 
Designation  post graduate resident 
Affiliation  Maulana Azad Medical college 
Address  department of Biochemistry Maulana Azad medical college Bahadur Shah Zafar Marg Delhi

Central
DELHI
110002
India 
Phone  9634608046  
Fax    
Email  biochemdranwar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lal Chandra 
Designation  Director Professor 
Affiliation  Maulana Azad medical college 
Address  department of Biochemistry Maulana Azad medical college Bahadur Shah Zafar Marg Delhi

Central
DELHI
110002
India 
Phone  9873167313  
Fax    
Email  drlchandra70@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lal Chandra 
Designation  Director Professor 
Affiliation  Maulana Azad medical college 
Address  department of Biochemistry Maulana Azad medical college Bahadur Shah Zafar Marg Delhi


DELHI
110002
India 
Phone  9873167313  
Fax    
Email  drlchandra70@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical college, Delhi university, Government of NCT of Delhi 
 
Primary Sponsor  
Name  Maulana Azad Medical college 
Address  Bahadur Shah Zafar marg New Delhi 110002 
Type of Sponsor  Government 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 Anwar Pervez  Maulana Azad Medical college  Bahadur Shah Zafar marg New Delhi 110002
Central
DELHI 		 9634608046

biochemdranwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Cases of stable and unstable angina, and follow cases of myocardial infarction 
 
ExclusionCriteria 
Details  All other cardiac disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
association of serum SIRT1 and metabolic syndrome in patients of coronary artery disease  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
association between pcsk9 gene polymorphism & serum SIRT1 in patients of coronary artery disease with metabolic syndrome  4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/10/2026 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [biochemdranwar@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The present study will be conducted with the primary objective of discovering association of serum SIRT1 and PCSK9 gene polymorphism with metabolic syndrome in patients of coronary artery disease The subjects(60) will be the diagnosed cases of coronary artery disease and divided into two groups one with metabolic syndrome and the other without metabolic syndrome based on the National Cholestrol Education Program Adult Treatment Panel III definition
After informed consent 5 ml of venous blood sample will be collected in the plain vial 3ml and EDTA vial 2ml Serum SIRT1 level will be estimated by ELISA technique following the protocol as per manual The genotyping for PCSK9  gene polymorphism will be done using Allele Specific Oligonucleotide Polymerase chain reaction ASO PCR and RFLP

 
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