| 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
|
|
|
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
|
|
|
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.
|