| CTRI Number |
CTRI/2019/08/020976 [Registered on: 29/08/2019] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing treatment guidelines for early detection of Heart disease through long-term monitoring of key body vitals. |
|
Scientific Title of Study
|
A Non-interventional, Observational Study for potential early detection of Heart disease based on, data analytics, through extended monitoring of key body vitals using a finger wearable wireless device (a ring) |
| Trial Acronym |
ODS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiron Varghese |
| Designation |
Professor and Head of Department of Cardiology |
| Affiliation |
St John’s Medical College and Hospital / Department of Cardiology |
| Address |
Department Of Cardiology,
3rd Floor
St. Johns Medical College Hospital, Sarjapur Road, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
9845167912 |
| Fax |
|
| Email |
drkiron@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lumina James BTECH MBA |
| Designation |
Clinical Research Coordinator |
| Affiliation |
St John’s Medical College Hospital / Department of Cardiology |
| Address |
Department Of Cardiology, 3rd Floor
St. Johns Medical College Hospital, Sarjapur Road, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
9740010647 |
| Fax |
|
| Email |
luminajsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiron Varghese |
| Designation |
Professor and Head of Department of Cardiology |
| Affiliation |
St John’s Medical College Hospital, Department of Cardiology |
| Address |
Department Of Cardiology,
3rd Floor
St. Johns Medical College Hospital, Sarjapur Road, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
918022065615 |
| Fax |
|
| Email |
drkiron@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Omnyk India Private Limited
Fernhill, Gardens, 46 HSR Layout, Sector 6, Bengaluru, 560102, Karnataka |
|
|
Primary Sponsor
|
| Name |
Omnyk India Private Limited |
| Address |
Fernhill, Gardens, 46 HSR Layout, Sector 6, Bengaluru, 560102, Karnataka |
| Type of Sponsor |
Other [Electronic Industry-Global] |
|
|
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 |
| Lumina James |
St John’s Medical College Hospital |
Cardio Research Unit, Department of Cardiology, 3rd Floor, St. Johns Medical College Hospital, Sarjapur Road, Koramangala
Bangalore
KARNATAKA |
9740010647
luminajsh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
| Jayadeva Institute of Cardiovascular Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Education and lifestyle changes |
Based on individual persons extended monitoring of body vitals, along with medical and family history a personalized program will be developed for life style changes. Checkup at regular interval of 3 months will be done to determine the efficacy of intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with a diagnosis for one of the cardiac ailments.
2. Patient willing to sign the consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients with acute illness needing critical care or having a definite psychiatric diagnosis.
2. Pregnant women or nursing mothers.
3. Patients with known skin allergies, or sensitivities to synthetic materials.
4. Any patient, who in the opinion of the investigator, are unlikely to fulfill the study requirements.
5. Patients currently enrolled in or are receiving investigational agents.
6. Patients with other comorbidities that may limit their life expectancy to less than 6 months.
7. Patients receiving pacing therapy (e.g., from a pacemaker); |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of heart health and continuously monitored (24/7) key body vitals for extended period of time |
1, 3 , 6 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of predictive analysis Algorithms, enabling new guidelines for the care of heart patients. |
6, 9, 12 and 15 months |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
09/09/2019 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Non-interventional, Observational Study for potential early
detection of Heart disease based on, data analytics, through extended
monitoring of key body vitals.Clinical prediction model
(CPM) developed based on long-term monitoring of Key body vitals has a good
potential to develop a protocol with the capability to finetune it for
personalized prediction. Using this model, we should be able to; increase the
probability of desired clinical outcomes, resulting in better care at reduced
costs for CVD patients. |