| CTRI Number |
CTRI/2024/01/061773 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidences of STEMI equivalents among classical STEMI in emergency department of AVBRH |
|
Scientific Title of Study
|
Incidence of STEMI equivalents in Emergency medicine department of AVBRH-A prospective cross sectional 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 |
Utkarsh Gaur |
| Designation |
junior resident |
| Affiliation |
DMIHER |
| Address |
Department of emergency medicine
AVBRH
Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09871795421 |
| Fax |
|
| Email |
utkarshgaur21@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gajanan Chavan |
| Designation |
HOD |
| Affiliation |
DMIHER |
| Address |
Department of emergency medicine
AVBRH
Wardha
MAHARASHTRA
442001
India |
| Phone |
7694014955 |
| Fax |
|
| Email |
gcgcny@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Utkarsh Gaur |
| Designation |
junior resident |
| Affiliation |
DMIHER |
| Address |
Department of emergency medicine
AVBRH
Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
09871795421 |
| Fax |
|
| Email |
utkarshgaur21@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave rural hospital and Jawaharlal Nehru medical college |
|
|
Primary Sponsor
|
| Name |
Utkarsh Gaur |
| Address |
Department of emergency medicine
AVBRH |
| 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 Utkarsh Gaur |
Acharya Vinoba Bhave rural hospital |
Sawangi(Meghe), Wardha
Wardha
MAHARASHTRA |
9871795421
utkarshgaur21@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Datta meghe institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I228||Subsequent ST elevation (STEMI) myocardial infarction of other sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 20 - 80 yrs both sexes
2. ECG suspected of Acute coronary syndrome
3. ECG suspected of STEMI variant
|
|
| ExclusionCriteria |
| Details |
1. Previous Myocardial Infarction in last 3 months
2. Patient not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidences of STEMI equivalent in ACS patient |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to determine the prognostic significance of these findings
2. To estimate the potential for advance research
|
4weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
08/02/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Acute myocardial infarction [AMI] is a leading cause
of high morbidity and mortality, and hence early identification and
intervention may result in improved outcome. Only a small
proportion result in diagnoses of ST elevation myocardial infarction (STEMI)
out of 6.9 million chest pain patients. AMI represents only 0.26% and this
results in total morbidity and mortality. Early cardiac repurfusions
significantly reduces mortality and morbidity. STEMI is defined as a new ≥ 1 mm
ST-elevation at the J-point in two contiguous leads. For males under 40 lead v2-v3 >
2.5mm ST elevation, for males 40 years >2mm ST elevation. For females
>1.5mm with no age bar.
Some
of the ECG morphologies dont meet the ST elevation criteria but suggest acute
coronary occlusion which will be benefitted with revascularization. Three such
patterns have been increasingly identified, 1. De winter T wave, 2. Wellen
syndrome, 3. AVR lead ST segment elevation.4. Posterior wall myocardial
infraction
|