| CTRI Number |
CTRI/2025/04/085904 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
In-hospital outcome and complications in cases of acute myocardial infarction and its association with random plasma glucose levels |
|
Scientific Title of Study
|
In-hospital outcome and complications in cases of acute myocardial infarction and its association with random plasma glucose levels at admission in teritary care hospital -a prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JITU MOL S |
| Designation |
Junior resident |
| Affiliation |
Gujarat medical council |
| Address |
GENERAL MEDICINE
GMC BHAVNAGAR,GUJARAT
Bhavnagar
GUJARAT
364002
India |
| Phone |
9496782061 |
| Fax |
|
| Email |
jitumols@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KRISHNA K LAKHANI |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
Gujarat medical council |
| Address |
DEPARTMENT OF MEDICINE
GMC BHAVNAGAR
Bhavnagar
GUJARAT
364002
India |
| Phone |
9429707472 |
| Fax |
|
| Email |
lakhanikrishna@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR JITU MOL S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Gujarat medical council |
| Address |
DEPARTMENT OF MEDICINE
GMC BHAVNAGAR
Bhavnagar
GUJARAT
364002
India |
| Phone |
9496782061 |
| Fax |
|
| Email |
jitumols@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Bhavnagar, Gujarat, India-364001 |
|
|
Primary Sponsor
|
| Name |
Government medical college Bhavnagar |
| Address |
Government medical college, Bhavnagar,Gujarat, India 364001 |
| Type of Sponsor |
Government medical college |
|
|
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 JITU MOL S |
SIR T HOSPITAL |
GENERAL MEDICINE DEPARTMENT
SIR T HOSPITAL,BHAVNAGAR ,GUJARAT
Bhavnagar
GUJARAT |
9496782061
jitumols@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE,GMC BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
Diagnosed as myocardial infarction |
|
| ExclusionCriteria |
| Details |
Unconscious patient
Past history of cardiac disease
Any injectables given before RPG assessment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mortality |
At 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart failure, arrhythmias,cardiogenic shock |
During in-hospital time |
|
|
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)
|
10/05/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This is a prospective observational study to assess the in- hospital outcome amd complications in cases of acute myocardial infarction and its association with random plasma glucose levels at admission. The objective is to check association of random plasma glucose levels with mortality and various complications like heart failure, arrhythmias, cardiogenic shock in a patient with myocardial infarction.
|