| CTRI Number |
CTRI/2025/03/081887 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the predictive value of simple blood count marker versus advanced cytokine biomarker for outcomes in off-pump coronary artery bypass surgery |
|
Scientific Title of Study
|
A prospective observational study to assess the predictive value of simple blood count based marker versus advanced cytokine biomarker for outcomes in off-pump coronary artery bypass surgery |
| 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 Sarah Iqbal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology And Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9027758674 |
| Fax |
|
| Email |
dr.sarah0512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANAZIR ATHAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE, Aligarh Muslim University |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JAWAHARLAL NEHRU MEDICAL COLLEGE, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8868056469 |
| Fax |
|
| Email |
drmanazirathar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANAZIR ATHAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE, AMU |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JNMCH, AMU
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8868056469 |
| Fax |
|
| Email |
drmanazirathar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of
anaesthesiology and
critical care, Jawaharlal Nehru
Medical College, AMU, Aligarh UTTAR
PRADESH 202002
India |
|
|
Primary Sponsor
|
| Name |
DR SARAH IQBAL |
| Address |
Department of anaesthesiology and critical care, Jawaharlal Nehru Medical College, AMU, Aligarh UTTAR PRADESH 202002 India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College AMU Aligarh |
Department of Anaesthesiology and Critical Care, JNMCH , AMU ,
Aligarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SARAH IQBAL |
Jawaharlal Nehru Medical College, AMU |
Department of
anaesthesiology and
critical care; JNMCH;
AMU Aligarh UTTAR
PRADESH 202002
India
Aligarh
UTTAR PRADESH |
9027758674
dr.sarah0512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NAME OF ETHICS COMMITTEE- INSTITUTIONAL ETHICS COMMITTEE, JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective off pump Coronary Artery Bypass Grafting.
Isolated CABG as per ESC/EACTS 2018 guidelines
Age more than 18 years
Either sex. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient undergoing repeat surgical procedures.
Patients receiving steroid, NSAIDS, immunomodulatory therapy
Patients having chronic HTN, chronic renal failure, serum ALT or AST level of twice the
baseline value, active infection (preoperative total leukocyte count of more than 11.000/mm3)
Those having history of recent CVA or MI (within 1 month)
Severe LV dysfunction (LVEF less than 30%)
Pre existing AF or utilizing antiarrhythmic therapy
Preexisting neurological disease
Patients of oncologic diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Acute Kidney Injury (AKI) in off-pump coronary artery bypass grafting
|
48 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- Atrial Fibrillation ( AF), and 3 Point Major Adverse Cardiovascular
Events (3P-MACE) which includes coronary heart disease death, fatal or
nonfatal ischemic stroke or myocardial infarction.
2- VIS Score
3- Total Mechanical ventilation time
4- Duration of ICU stay
5- 30- Day mortality |
30 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Keeping in
mind the inflammatory background of coronary artery disease, currently various inflammatory markers are being used to predict the outcomes
in patients of off pump cardiac surgery like IL-1, IL-6, TNF- alpha etc. Since these
tests are very costly and there is growing evidence presenting the
role of whole blood count inflammatory
markers in prediction of morbidity and
mortality in coronary artery diseases we
are planning this observational study to assess
the predictive value of simple
blood count
based
markers versus advanced cytokine biomarkers for outcomes in off-pump coronary
artery bypass surgery. |