| CTRI Number |
CTRI/2026/01/101475 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Risk of Heart Injury in Cancer Patients Undergoing Non-Heart Surgery |
|
Scientific Title of Study
|
Myocardial Injury After Non Cardiac Surgeries[MINS] In Major Cancer Surgeries: A Prospective Observational Cohort Study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishkarsh Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Room No 139 DRBRAIRCH , Ansari Nagar South DELHI India
New Delhi
DELHI
110029
India |
| Phone |
90913310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishkarsh Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Room No 139 DRBRAIRCH , Ansari Nagar South DELHI India
New Delhi
DELHI
110029
India |
| Phone |
90913310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishkarsh Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Room No 139 DRBRAIRCH , Ansari Nagar South DELHI India
New Delhi
DELHI
110029
India |
| Phone |
90913310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Science |
| Address |
Ansari Nagar South DELHI 110029,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 |
| Nishkarsh Gupta |
All India Institute Of Medical Science Dr.BRA irch |
Ansari Nagar South DELHI India
New Delhi
DELHI |
90913310014
drnishkarsh@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committe all India institute of medical science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All Consenting Patients |
|
| ExclusionCriteria |
| Details |
Refusal of Consent
Recent Myocardial Infarction
Autoimmune Disease
Acute or Chronic Kidney Injury
Liver Failure
Sepsis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of Cancer Patients Having Myocardial Injury Post Non Cardiac Surgery |
24 hours, 48hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of Patients Developing Major Adverse Cardiac Events |
within 30 days of surgery |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="207" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2026 |
| Date of Study Completion (India) |
31/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - journals
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Myocardial injury after non cardiac surgery can be defined as a clinical condition marked by elevated cardiac troponin levels following non cardiac surgery, which may occur with or without ischemic symptoms. The chances of patient developing MINS is higher in cancer patients due to adjuvant treatments and cancer itself. Hence this study will be helpful in identifying MINS and MACE in cancer patients. All consenting patients whose surgery is expected to last more than 2 hours will be selected for the study. Preoperative history, clinical and demographic parameters will be recorded and blood samples will be tested for Hs-Troponin T, NT Pro-BNP, CKMB,LDH. Post operatively the same markers will be tested at 24 hours and 48 hours . myocardial injury will be diagnosed according to the VISION diagnostic criteria . patient will be monitored for Major Adverse Cardiac Event during their hospital stay . |