| CTRI Number |
CTRI/2013/06/003733 [Registered on: 10/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
10/06/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A data collection project on patients with Irregular rhythms of heart after surgical operation. |
|
Scientific Title of Study
|
A prospective observational study of post operative Ventricular Arryhythmias |
| Trial Acronym |
POVA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balbir Singh |
| Designation |
Chairman, Department of Electrophysiology |
| Affiliation |
Medanta-The Medicity |
| Address |
Sector-38, Gurgaon, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
9818898479 |
| Fax |
0124-4834468 |
| Email |
balbir.singh@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balbir Singh |
| Designation |
Chairman, Department of Electrophysiology |
| Affiliation |
Medanta-The Medicity |
| Address |
Sector-38, Gurgaon, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
9818898479 |
| Fax |
0124-4834468 |
| Email |
balbir.singh@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balbir Singh |
| Designation |
Chairman, Department of Electrophysiology |
| Affiliation |
Medanta-The Medicity |
| Address |
Sector-38, Gurgaon, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
9818898479 |
| Fax |
0124-4834468 |
| Email |
balbir.singh@medanta.org |
|
|
Source of Monetary or Material Support
|
| Medanta The Medicity
Sec-38,Gurgaon,Haryana,India. |
|
|
Primary Sponsor
|
| Name |
MedantaThe Medicity |
| Address |
Sector-38, gurgaon, Haryana, 122001, India |
| 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 Balbir Singh |
Medanta-The Medicity |
Sector-38. gurgaon, Haryana, 122001, India
Gurgaon
HARYANA |
9818898479
0124-4834468
balbir.singh@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Ventricular Arrhythmias, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing cardiac surgical procedure (repeat angiography,insertion of an Intraaortic Balloon Pump,insertion of a defibrillator or Electrophtysiology studies) at Medanta the Medicity
2. Post operative Ventricular arrhythmia
|
|
| ExclusionCriteria |
| Details |
Data for all the patients would be reviewed. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The incidence of any new onset recurrent or self reverting episode of sustained Ventricular Tachycardia VT ie lasting 30 seconds or requiring antiarrhythmic therapy cardioversion will be recorded. |
The incidence of any new onset recurrent or self reverting episode of sustained Ventricular Tachycardia VT ie lasting 30 seconds or requiring antiarrhythmic therapy cardioversion will be recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The incidence of non sustained VT ie VT lasting 30 seconds
2. To review the various risk factors in the patients of sustained and non sustained VT
3. Short term outcome of the patients will be assessed by mortality, days of ICU stay, days of hospital stay, and other complications
|
12 month |
|
|
Target Sample Size
|
Total Sample Size="3600"
Sample Size from India="3600"
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)
|
01/05/2013 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The details would be available after the trial would finish. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The data collection project aims to identify high risk patient and improve standard of care at the hospital by instating preventive measures,This study also aims to asess the incidence of post operative ventricular arrythmias before discharge from the hospital.As the new onset Post operative ventricular arrythmia after cardiac surgey is uncommon and has prognostic value is the rationale/background for this study.
This Study will help us to identify predictors which will help in improving primary and secondary strategies and thus improving morbidity and mortality due to post operative ventricular arrythmias. |