| CTRI Number |
CTRI/2021/04/032888 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
ECG IN HEART ATTACK |
|
Scientific Title of Study
|
A STUDY OF FRONTAL QRST ANGLE IN PATIENTS 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 |
JATIN PRAVEEN PANCHAL |
| Designation |
JUNIOR RESIDENT, DEPARTMENT OF GENERAL MEDICINE |
| Affiliation |
BLDE (DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
ROOM NO-309, DEPARTMENT OF GENERAL MEDICINE, B.L.D.E. (DEEMED TO BE UNIVERSITY), SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA.
ROOM NO-309, DEPARTMENT OF GENERAL MEDICINE, B.L.D.E. (DEEMED TO BE UNIVERSITY), SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
9769496369 |
| Fax |
|
| Email |
jatin1092@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BADIGER SHARANABASAWAPPA |
| Designation |
PROFESSOR AND HEAD, DEPARTMENT OF GENERAL MEDICINE |
| Affiliation |
B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
ROOM NO-309, DEPARTMENT OF GENERAL MEDICINE, B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA.
ROOM NO-309, DEPARTMENT OF GENERAL MEDICINE, B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448434927 |
| Fax |
|
| Email |
sharanrb@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BADIGER SHARANABASAWAPPA |
| Designation |
PROFESSOR AND HEAD, DEPARTMENT OF GENERAL MEDICINE |
| Affiliation |
B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
ROOM NO-309, DEPARTMENT OF GENERAL MEDICINE, B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA.
ROOM NO-309, DEPARTMENT OF GENERAL MEDICINE, B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
9448434927 |
| Fax |
|
| Email |
sharanrb@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR JATIN PRAVEEN PANCHAL |
| Address |
B.L.D.E (DEEMED TO BE UNIVERSITY)SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA-586103. |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| JATIN PRAVEEN PANCHAL |
B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
ROOM NO-309, DEPARTMENT OF GENERAL MEDICINE, B.L.D.E(DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA-586103, KARNATAKA.
Bijapur
KARNATAKA |
9769496369
jatin1092@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS ADMITTED WITH ACUTE MYOCARDIAL INFARCTION (BOTH STEMI AND NSTEMI) |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WITH UNSTABLE ANGINA
2.PATIENTS HAVING BUNDLE BRANCH BLOCK ON ECG(LBBB OR RBBB)
3.PATIENT ON TEMPORARY OR PERMANENT PACEMAKER
4.PATIENTS WITH OLD ISCHEMIC HEART DISEASE.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| AN ABNORMAL FRONTAL QRST ANGLE CAN BE USED TO PREDICT ADVERSE CARDIAC EVENTS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION |
14 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| THE STUDY WILL BE ABLE TO HELP PATIENTS WITH SIMILAR COMPLAINS AND GIVE US AN IDEA ABOUT THE LIKELY COMPLICATIONS AND HELP US IN TREATING THE PATIENTS BETTER.THE STUDY WILL HELP OTHERS FOR FURTHER STUDIES ON THE TOPIC. |
3 MONTHS FROM THE DATE OF COMPLETION OF STUDY. |
|
|
Target Sample Size
|
Total Sample Size="71"
Sample Size from India="71"
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)
|
20/04/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS A CROSS-SECTIONAL STUDY, FRONTAL QRST ANGLE AS A PREDICTOR OF IN-HOSPITAL OUTCOME OF ADVERSE CARDIAC EVENTS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION. IT WILL BE CONDUCTED IN B.L.D.E. (DEEMED TO BE UNIVERSITY) SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA. A TOTAL OF 71 PATIENTS AFTER APPLYING THE INCLUSION AND EXCLUSION CRITERIA WILL BE STUDIED. A 12 LEAD SURFACE ELECTROCARDIOGRAM ON ADMISSION WILL BE TAKEN WHICH WILL BE USED FOR THE DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION AND THE ASSESSMENT OF FRONTAL QRST ANGLE. IF PATIENT HAS THE FRONTAL QRST ANGLE OF MORE THAN 100 DEGREES IS AT RISK FOR DEVELOPMENT OF IN HOSPITAL ADVERSE CARDIAC EVENTS.THE PRIMARY OUTCOME OF THE STUDY IS TO PROVE THAT AN ABNORMAL FRONTAL QRST ANGLE CAN BE USED TO PREDICT ADVERSE CARDIAC EVENTS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION. THE SECONDARY OUTCOME OF THE STUDY IS TO HELP PATIENTS WITH SIMILAR COMPLAINS AND GIVE US AN IDEA ABOUT THE LIKELY COMPLICATIONS AND HELP US IN TREATING THE PATIENTS BETTER, INTERVENE EARLIER AND REDUCE THE HOSPITAL STAY OF THE PATIENT, IN TURN, REDUCING THE FINANCIAL BURDEN ON THE PATIENT.THE STUDY WILL HELP OTHERS FOR FURTHER STUDIES ON THE TOPIC.
|