| CTRI Number |
CTRI/2023/07/054604 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
30/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to study the association of two diseases Heart Attack and kidney failure. |
|
Scientific Title of Study
|
Incidence and prognosis of Acute Kidney Injury in patients of Acute Myocardial Infarction in a University Hospital in Rajasthan |
| 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. Hritvik Jaiswal |
| Designation |
PG Resident |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of General Medicine, Pacific Medical College and Hospital, Bedla, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9108768815 |
| Fax |
|
| Email |
hrtvkjaiswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kalu Ram Sharma |
| Designation |
Head of the Department |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of General Medicine, Pacific Medical College and Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
8619166164 |
| Fax |
|
| Email |
rbharos259@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Hritvik Jaiswal |
| Designation |
PG Resident |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department Of General Medicine, Pacific Medical College and Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9108768815 |
| Fax |
|
| Email |
hrtvkjaiswal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medical College and Hospital, Bedla, Udaipur, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital |
| Address |
Bedla, Udaipur, Rajasthan |
| Type of Sponsor |
Private 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 Hritvik Jaiswal |
Pacific Medical College and Hospital |
Department of General Medicine, Pacific Medical College and Hospital
Udaipur
RAJASTHAN |
9108768815
hrtvkjaiswal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pacific Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21||Acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute Myocardial infarction |
|
| ExclusionCriteria |
| Details |
Pre Existing Cardiac diseases, pre-existing CKD |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Acute Kidney Injury |
At the time of admission in hospital ( Day-1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
at discharge |
|
|
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)
|
10/07/2023 |
| 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
|
This study is an observational cohort study to find out the incidence and prognosis of Acute Kidney Injury in patients of Acute Myocardial Infarction. It is being done at Pacific Medical college and Hospital ,Udaipur.Acute Kidney Injury, if not identified & intervened at the earliest, may become partly irreversible or even progress to chronic kidney disease, which has a profound impact on cardiovascular outcomes in patients with acute coronary syndromes as well as in the general population . Worsening of renal function during admission for myocardial infarction is a powerful and independent predictor of in-hospital and 1-year mortality as per previous studies. The purpose of this study is to evaluate the incidence of Acute Kidney Injury, as defined by the KDIGO, in the acute phase of a myocardial infarction, thereby making vigorous efforts to preserve renal function as we attempt to salvage and protect cardiac muscle. |