| CTRI Number |
CTRI/2022/01/039773 [Registered on: 27/01/2022] Trial Registered Prospectively |
| Last Modified On: |
25/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
TO KNOW PERIOPERATIVE CARDIAC COMPLICATIONS IN PATIENTS WITH HEART DISEASE UNDERGOING MAJOR ONCOSURGERIES:A RETROSPECTIVE STUDY |
|
Scientific Title of Study
|
INCIDENCE OF PERIOPERATIVE CARDIAC COMPLICATIONS IN PATIENTS WITH HEART DISEASE UNDERGOING MAJOR ONCOSURGERIES:A RETROSPECTIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Operation theatre Anesthesia cubicle Department of Anaesthesia Malabar Cancer Centre Thalassery
rOOM NO 1,Operation theatre Anesthesia cubicle Department of Anaesthesia Malabar Cancer Centre Thalassery
Kannur
KERALA
670103
India |
| Phone |
9765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
ROOM NO 1,Operation theatre Anesthesia cubicle Department of Anaesthesia Malabar Cancer Centre Thalassery
ROOM NO 1,Operation theatre Anesthesia cubicle Department of Anaesthesia Malabar Cancer Centre Thalassery
Kannur
KERALA
670103
India |
| Phone |
9765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Opneja |
| Designation |
Assistant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
ROOM NO 1,Operation theatre Anesthesia cubicle Department of Anaesthesia Malabar Cancer Centre Thalassery
ROOM NO 1,Operation theatre Anesthesia cubicle Department of Anaesthesia Malabar Cancer Centre Thalassery
Kannur
KERALA
670103
India |
| Phone |
9765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Malabar Cancer Centre |
| Address |
Malabar Cancer Centre
Thalassery ,Kodiyeri-670103 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Sonali Opneja |
Malabar cancer centre |
Room no 1,Anesthesia Cubicle Department of anesthesia Operation Theatre
Kannur
KERALA
Kannur
KERALA |
9765635728
sopneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institution ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
having any heart disease |
|
| ExclusionCriteria |
| Details |
ASA 5 and 6
Recurrent surgeries |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of perioperative cardiac complications in patients undergoing major oncosurgeries |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the risk factors for cardiac complications |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/01/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study will tell about the incidence of perioperative cardiac complications and risk factors associated with it. |