| CTRI Number |
CTRI/2025/04/084465 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Heart problems in patients with rheumatoid arthritis and their link to disease severity
|
|
Scientific Title of Study
|
Cardiac manifestations in patients of Rheumatoid arthritis and its association with disease severity |
| 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 Anandswarup Chaudhari |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad medical college |
| Address |
Medicine department,Mamc campus ,New Delhi
Central
DELHI
110002
India |
| Phone |
7620565397 |
| Fax |
|
| Email |
anandc260897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
medicine department,MAMC , NEW DELH
Central
DELHI
110022
India |
| Phone |
9910555433 |
| Fax |
|
| Email |
pradeepkumar.pacific@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandswarup Chaudhari |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad medical college |
| Address |
Medicine department, Mamc campus New Delhi
Central
DELHI
110002
India |
| Phone |
7620565397 |
| Fax |
|
| Email |
anandc260897@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated lok nayak hospital,G.I.P.M.E.R, And G.N.E.C.Hospitals, New Delhi-110002 New Delhi,Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Anandswarup Chaudhari |
lok nayak hospital,G.I.P.M.E.R,And G.N.E.C.Hospitals |
2,bahadur shah zafar marg,near Delhi gate, Maulana Azad medical college campus,Balmiki basti, NewDelhi-110002
Central
DELHI |
7620565397
anandc260897@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana azad medical college Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M053||Rheumatoid heart disease with rheumatoid arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nill |
Nill |
| Comparator Agent |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Rheumatoid arthritis diagnosed according to the American college of Rheumatology-European league Against Rheumatism 2010 criteria |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the cardiac manifestations in patients of Rheumatoid arthritis and the association of cardiac manifestation with disease severity in patients of Rheumatoid arthritis |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the association of cardiac manifestations with biochemical markers[ESR,CRP,RA factor,Anti CCP antibodies] |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
19/04/2025 |
| 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 Yet Recruiting |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anandc260897@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients of Rheumatoid arthritis (age>18 years) diagnosed according to American college of Rheumatology-European league against Rheumatism 2010 criteria will be enrolled in this study. |