| CTRI Number |
CTRI/2024/09/074534 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Heart Rhythm Abnormalities among Urban Dwelling Poor - An observational follow up study |
|
Scientific Title of Study
|
Study of Arrhythmias and Biomarkers in Vulnerable Urban Dwellers to Assess
Pathophysiological Nexus for Cardiovascular Outcomes |
| Trial Acronym |
SAVDHAN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Kumar Bandaru |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
4th Floor, Department of General Medicine, Medical College and Hospital, Sanathnagar
Hyderabad
TELANGANA
500036
India |
| Phone |
9885633040 |
| Fax |
|
| Email |
drrajivb85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Kumar Bandaru |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
4th Floor, Department of General Medicine, Medical College and Hospital, Sanathnagar
Hyderabad
TELANGANA
500036
India |
| Phone |
9885633040 |
| Fax |
|
| Email |
drrajivb85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajiv Kumar Bandaru |
| Designation |
Associate Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
4th Floor, Department of General Medicine, Medical College and Hospital, Sanathnagar
Hyderabad
TELANGANA
500036
India |
| Phone |
9885633040 |
| Fax |
|
| Email |
drrajivb85@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Sanathnagr, Hyderabad, Telangana, India-500036 |
| Monitra Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Monitra Healthcare Private limited |
| Address |
T-Hub 2.0, Raidurgam,
Knowledge City, Hyderabad,
Telangana - 500081 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
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 Rajiv Kumar Bandaru |
ESIC Medical College and Hospital |
Room No. 406, 4th Floor, Department of General Medicine,Medical College Hospital Block, Sanathnagar
Hyderabad
TELANGANA |
9885633040
drrajivb85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College and Hospital and ESIC Super speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I498||Other specified cardiac arrhythmias, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Non Laboratory INTERHEART Risk score above 10
2. Poor socio-economic urban living
demography |
|
| ExclusionCriteria |
| Details |
1. known cardiac rhythm abnormalities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major Adverse Cardiovascular Event |
Major Adverse Cardiovascular Event |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hospitalisation |
12 months |
| New onset Atrial Fibrillation |
12 months |
| New onset cardiac arrhythmia |
12 months |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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)
|
15/10/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
INTERHEART Risk Score is a validated non laboratory measures based risk score for predicting new onset major acute cardiovascular events in general population. Combining this with a baseline holter monitoring for cardiac rhythm abnormalities and established biomarkers for cardiovascular disease, can improve our case detection for poor people living in urban settings. This study will give us important information on the prevalence of high risk population among the urban poor, the prevalence of a abnormal heart rhythm or a biomarker and their correlation to the incidence of major cardiovascular events over a period of 12 months. The study is awaiting CTRI regsitration approval for recruiting patients into the cohort. The study will be initiated as soon as CTRI registration number is issued. |