| CTRI Number |
CTRI/2024/07/070361 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Heart rhythm disturbance in patients of coronary bypass surgery as an indicator of sickness and death |
|
Scientific Title of Study
|
The occurrence of postoperative
supraventricular arrhythmia in
off pump coronary artery bypass grafting as a predictor for postoperative morbidity and mortality |
| 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 Abhin Mohan |
| Designation |
Junior Resident |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anesthesiology Himalayan Institute of Medical Sciences Jolly Grant Dehradun 248140 Uttarakhand India
Department of Anesthesiology Himalayan Institute of Medical Sciences Jolly Grant Dehradun 248140 Uttarakhand India
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7983609541 |
| Fax |
|
| Email |
abhin18mohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Oberoi |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of medical sciences |
| Address |
Department of Anesthesiology Himalayan Institute of Medical Sciences Jolly Grant Dehradun 248140 Uttarakhand India
Department of Anesthesiology Himalayan Institute of Medical Sciences Jolly Grant Dehradun 248140 Uttarakhand India
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8006329039 |
| Fax |
|
| Email |
deepakoberoi@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Oberoi |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Himalayan Institute of Medical Sciences Jolly Grant Dehradun 248140 Uttarakhand India
Department of Anaesthesiology Himalayan Institute of Medical Sciences Jolly Grant Dehradun 248140 Uttarakhand India
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8006329039 |
| Fax |
|
| Email |
deepakoberoi@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
| Himalayan Institute of Medical Sciences University Jolly Grant Dehradun 248140 Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Dr Deepak Oberoi |
| Address |
Department of Anaesthesiology Himalayan Institute of Medical Sciences Jolly Grant Dehradun 248140 Uttrakhand India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Priya Ramakrishnan |
Himalayan institute of medical sciences anaesthesia department |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Oberoi |
Himalayan Institute of Medical Sciences |
CTVS ICU Third Floor Department oF Anaesthiology Himalayan Hospital SRHU Campus
Dehradun
UTTARANCHAL |
8006329039
deepakoberoi@srhu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swami Rama Himalayan University |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Group of patient – undergoing off pump
coronary artery bypass grafting
-All patients giving written informed consent |
|
| ExclusionCriteria |
| Details |
-On pump CABG
-Pre existing supraventricular arrhythmia
-Valvular heart surgery
-Pre-existing pulmonary artery hypertension
-OLD MI,
-Ejection fraction less than 40% |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To determine the occurence of morbidity, mortality and number of other risk factors associated in various types of post operative Supraventricular Arrhythmias(SVA) in patients undergoing Off pump CABG. |
1) Immediately after the shifting patient to post operative CTVS ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To estimate the occuerence of Post operative Supraventricular Arrythmias in Off Pump Coronary Artery Bypass Grafting (OPCAB).
2) Comparison of various types of SVA in terms of their associated morbidity & mortality.
3) Association of perioperative risk factors with developement of SVA. |
1)Immediately after the shifting patient to post operative CTVS ICU |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
01/08/2024 |
| 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="1"
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
|
Coronary artery bypass grafting (CABG) remains the “gold standard†treatment for multi-vessel coronary artery disease, particularly for three-vessel or left main coronary artery disease. Supraventricular arrhythmias are a group of cardiac arrhythmias that originate at or above the atrioventricular node and have a narrow QRS complex (<120 ms) . Supraventricular arrhythmias include Atrial fibrillation , Atrial flutter , Supraventricular tachycardia including Paroxysmal supraventricular tachycardia (PSVT). Aim of the study is To determine the occurence of morbidity, mortality and number of other risk factors associated in various types of post operative Supraventricular Arrhythmias(SVA) in patients undergoing Off pump CABG.
|