| CTRI Number |
CTRI/2022/10/046802 [Registered on: 26/10/2022] Trial Registered Prospectively |
| Last Modified On: |
11/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evulation of development and prognostic of cardiogenic shock between the patient with acute myocardial infarction |
|
Scientific Title of Study
|
Assessment of outcome and predictors of cardiogenic shock among the patient with acute
myocardial infarction
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen C |
| Designation |
Post Graduation Student |
| Affiliation |
MCHP,MAHE,Manipal |
| Address |
Room No 212,2nd Floor,Department Of CVT,MCHP,MAHE,Manipal,Udupi
Room No 212,2nd Floor,Department Of CVT,MCHP,MAHE,Manipal,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9843787802 |
| Fax |
|
| Email |
chenniappannaveen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnanandha Nayak |
| Designation |
Associate professor and Head |
| Affiliation |
MCHP, MANIPAL |
| Address |
Room No 212,2nd Floor,Department Of CVT,MCHP,MAHE,Manipal,Udupi
Room No 212,2nd Floor,Department Of CVT,MCHP,MAHE,Manipal,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9449215487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnanandha Nayak |
| Designation |
Associate professor and Head |
| Affiliation |
MCHP, MANIPAL |
| Address |
Room No 212,2nd Floor,Department Of CVT,MCHP,MAHE,Manipal,Udupi
Room No 212,2nd Floor,Department Of CVT,MCHP,MAHE,Manipal,Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9449215487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology, Kasturba Medical College and Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical college and Hospital |
| Address |
Department of Cardiology, Kasturba Medical College and Hospital, Manipal |
| 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 |
| Naveen C |
Kasturba Hopital |
Room 212,2nd Floor Department of Cardiology, MCHP, MAHE, MANIPAL
Udupi
KARNATAKA |
9843787802
chenniappannaveen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient who admitted with acute myocardial infraction who are under going primary PCI |
|
| ExclusionCriteria |
| Details |
Multivessel disease
Post CABG status
coronary anomalies
Re-Myocardial Infraction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Death
Reintervention
Access site bleeding
Transfusion needed
Stroke
Vascular complication
Pseudo Aneurysm
Renal Failure
Mitral Regurgitation
Pericardial effusion
ventricular septal rupture |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evulation of outcome and forecaster of cardiogenic shock among the patient with acute myocardial infarction |
one year |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/11/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study to estimation the predictors of cardiogenic shock among the patient with acute myocardial infarction Purpose To compare the predictable short term outcome in end organ hypo perfusion and anoxia in acute myocardial infarction with cardiogenic shock and without cardiogenic shock To compare with mortality and revascularization short term outcome in patients who have acute myocardial infarction with cardiogenic shock and without cardiogenic shock To assess the cardiovascular predictors and results of cardiogenic shock among the patients in acute myocardial infarction
Need of study There are multiple factors that can associated with the poor outcome in acute myocardial infarction |