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CTRI Number  CTRI/2024/05/068036 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 28/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Cardiovascular risk in psoriasis patient 
Scientific Title of Study   Correlate the atherogenic indices with cardiovascular risk in psoriasis patients:A cross-sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shahrukh Alam 
Designation  Post graduate student 
Affiliation  All India Institute of Medical Sciences 
Address  Department of dermatology, All India Institute of Medical Sciences, Bathinda, Punjab

Bathinda
PUNJAB
151001
India 
Phone  9304066204  
Fax    
Email  shahrukhsra010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Kavita Poonia 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of dermatology, All India Institute of Medical Sciences, Bathinda, Punjab

Bathinda
PUNJAB
151001
India 
Phone  9646091743  
Fax    
Email  kavitapoonia777@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Kavita Poonia 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of dermatology, All India Institute of Medical Sciences, Bathinda, Punjab

Bathinda
PUNJAB
151001
India 
Phone  9646091743  
Fax    
Email  kavitapoonia777@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, AIIMS Bathinda, Mandi Dabwali Road, Bathinda, Punjab 151001 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bathinda Punjab 
Address  All India Institute of Medical Sciences, Jodhpur Ramana, Dabwali Road, Bathinda, Punjab, 151001 
Type of Sponsor  Research institution and hospital 
 
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 Shahrukh Alam  All India Institute of Medical Science  Room no- 2109, 1B, department of dermatology, AIIMS Bathinda
Bathinda
PUNJAB 
9304066204

shahrukhsra010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Bathinda Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L409||Psoriasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients above 18 years of age
2.Patients of psoriasis who have not taken any form of treatment in the last 1 month.
3.Patients who are willing to sign the written consent form before participating in the study
 
 
ExclusionCriteria 
Details  1.Patient having history of chronic hepatic and renal disease, diabetes mellitus, cardiovascular diseases and malignancies.
2.Those with history of chronic smoking, drug abuse and having morbid obesity (BMI above 30kg/square metre).
3.Patients who are taking lipid-lowering agents.
4.Patients having chronic inflammatory disease, immunological disorders with associated endothelial dysfunction.
5.Pregnant and lactating female.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate the atherogenic indices with cardiovascular risk in psoriasis patients  Outcome will be assessed at the time of patient visit 
 
Secondary Outcome  
Outcome  TimePoints 
To study any correlation between Atherogenic Indices & CIMT with disease severity
 
Outcome will be assessed at the time of patient visit 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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)   08/06/2024 
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  

Patient will be enrolled in the department of dermatology . History taking will be done including onset, duration and course of the disease. Clinical Examination will be done to detect association (nail changes and any other autoimmune disease) and to determine the extent of Psoriasis Vulgaris, which will be assessed using the Psoriasis Area and Severity Index (PASI) Score.

Anthropometric examination including Height, Weight, Body Mass Index(BMI), Waist circumference, Hip circumference, waist to hip ratio, will be done and baseline laboratory examinations including LFT, RFT, RBS and lipid profile consisting of cholesterol, low density lipoprotein(LDL), high density lipoprotein (HDL),Triglyceride and VLDL will be included. Blood samples will be collected after overnight fasting for analysis using (mention analyser used in biochem department)

Atherogenic Indices including Atherogenic Index of Plasma (AIP), Castelli Risk Index I and II (CRI), Atherogenic Coefficient (AC), and non-high density lipoprotein cholesterol (HDLc) (NHC)will be used to assess the risk of cardiovascular disease. These indices are calculated as:

·AIP = Log (serum triglyceride/serum HDLc).

·CRI-I = Serum total cholesterol/Serum HDLc.

·CRI-II = Serum low-density lipoprotein (LDL)cholesterol/Serum HDLc

·AC=(Serum total cholesterol-Serum HDLc)/HDLc.

·NHC=(Serum total cholesterol-Serum HDLc)

CIMT: Double-check the CIMT values on both sides to achieve reproducibility, the mean values will be generated for CIMT. The American Institute of Ultrasound in Medicine’s (AIUM) standards will serve as the foundation for the common carotid artery (CCA) sonographic protocol.

Patient’s Proforma (Annexure-I) will be filled for all the patients included in the study. 



 
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