| CTRI Number |
CTRI/2022/05/042757 [Registered on: 23/05/2022] Trial Registered Prospectively |
| Last Modified On: |
20/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of C-Reactive Protein in various heart risk score in Rheumatoid Arthritis |
|
Scientific Title of Study
|
Correlation of C reactive protein with various Cardiovascular risk scores in patient with rheumatoid arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Chaudhary |
| Designation |
Resident |
| Affiliation |
RUHS-CMS |
| Address |
RUHS-CMS, Pratap Nagar,
Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
7733887446 |
| Fax |
|
| Email |
driftyriders@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Sharma |
| Designation |
Senior Professor |
| Affiliation |
RUHS-CMS |
| Address |
Department of Biochemistry
RUHS-CMS, Pratap Nagar, Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
sonalisharma14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Sharma |
| Designation |
Senior Professor |
| Affiliation |
RUHS-CMS |
| Address |
Department of Biochemistry
RUHS-CMS, Pratap Nagar, Jaipur
Pratap Nagar, Jaipur
Dausa
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
sonalisharma14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biochemistry, RUHS-CMS associated RDBP Jaipuria hospital |
|
|
Primary Sponsor
|
| Name |
Dinesh Chaudhary |
| Address |
RUHS-CMS, Pratap Nagar, Jaipur |
| Type of Sponsor |
Other [dinesh chaudhary] |
|
|
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 Dinesh Chaudhary |
R.D.B.P. Jaipuria hospital |
Room No.53, Central lab, Department of Biochemistry,
RUHS HMS
Jaipur
RAJASTHAN |
7733887446
driftyriders@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS CMS ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirmed cases of RA according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria18 which include details of
Joint involvement. Minimum 1 small joint and >2 large joint
Serology test results. Positive rheumatoid factor or positive anti citrulline protein antibody (ACPA)
Acute-phase reactant test results. Abnormal CRP or abnormal ESR
Duration of symptoms. More than 6 months
2.Disease.duration >2years
|
|
| ExclusionCriteria |
| Details |
1.Pre-existing cardio vascular disease
2.On statin treatment
3.Diabetes mellitus
4. Chronic kidney disease
5. Hypertension
6. Pregnant and lactating women
7.Thyroid dysfunction
8.Cancer
9.Seriously ill patient
10.Inability to give inform consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Evaluation of cardiovascular risk in Rheumatoid Arthritis patient using different algorithms for CV risk estimation and their correlation with CRP level |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Effect of anthropometric parameters on Rheumatoid Arthritis
3. To assess disease severity in Rheumatoid Arthritis patients and its relation to CV risk score
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
24/05/2022 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid arthritis (RA) is a chronic systemic auto immune disease with a worldwide prevalence of approximately 0.5% to 1% among adults. In India prevalence of RA range 0.28 to 0.7% .Atherosclerosis is now recognised as an inflammatory disease, and the two diseases, atherosclerosis and RA, are considered to share many similarities . Patients with RA experience elevated risk of cardiovascular disease (CVD) including 50–70% higher risk of heart disease than the general population.Patient of RA often have elevated levels of circulating inflammatory markers such as C-reactive protein (CRP). CRP,Overall CVD risk in RA patient has two components. The first one is set of traditional risk factor for the general population. The interheart study has demonstrated the effect well- known factor associated with atherosclerosis. The second component is a set of risk factors such as inflammatory mediator, treatment and disease activity in RA Patients
with RA have an increased risk of mortality and main cause is CV related
events. RA patient have chronic high grade inflammation which contribute towards
development premature atherosclerosis and CV events. The present study is
undertaken to evaluate the CV risk using traditional CV risk algorithms (Framingham
risk score, QRISK, INTERHEART risk score)for management of RA and to analyse association
of inflammatory marker to the traditional CV risk factors.
|