| CTRI Number |
CTRI/2020/11/029102 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
11/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Type of Heart Attack score in STEMI ( a type of heart attack) and its relation with blocks in Heart Vessel. |
|
Scientific Title of Study
|
Global Registry of Acute Coronary Events (GRACE) score in ST-Elevation Myocardial Infarction (STEMI) and its correlation with coronary angiography. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayvir Atodariya |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
Deptartment of cardiology
Kasturba Hospital
Kasturba Medical College
Madhava Nagar , Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kardiiakos@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh P |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Cardiology, 3rd Floor, Kasturba Hospital, Madhav
Nagar, Manipal. Udupi KARNATAKA 576104 India
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ganeshbmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh P |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
Deptartment of cardiology
Kasturba Hospital
Kasturba Medical College
Madhava Nagar , Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ganeshbmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Jayvir Atodariya |
Kasturba Hospital |
Room no. 36,
Department of
Cardiology, 3rd floor,
Kasturba Medical
College and Hospital,
Tiger Circle Road,
Madhava Nagar,
Manipal, Udupi.
Karnataka. PIN -
576104
Udupi
KARNATAKA
Udupi
KARNATAKA |
8088662710
kardiiakos@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with evidence of ST-Elevation Acute Myocardial Infarction according to Third Universal Definition of Myocardial Infarction(MI) with age between 18 years to 70 years. |
|
| ExclusionCriteria |
| Details |
Patients without evidence of ST-Elevation Acute Myocardial Infarction. Patients with post thrombolysis, previous PCI/CABG, post-operative, Malignancy, Patients < 18 & > 70 Years, Not signing consent, Pregnant women are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of CAD using Gensini score |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ALL-CAUSE DEATH
NON-FATAL-MI
STROKE
REPEAT REVASCULARIZATION |
ONE MONTH |
|
|
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)
|
16/11/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO PUBLICATIONS YET ON THIS STUDY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Atherosclerosis is a major cause of cardiovascular disease (CVD). Coronary atherosclerosis is the main cause of ST elevation acute myocardial infarction (STEMI). Recently, cardiologists have begun studying risk stratification in patients with acute coronary syndrome (ACS) to identify the severity and complexity of CAD. The extent and severity of atherosclerotic disease of coronary arteries are highly variable. Although GRACE risk score is an important and validated tool for assessing prognosis however, it is unknown whether GRACE score is useful in predicting the severity of lesions assessed by coronary angiography in patients with STEMI. Several international reports have shown positive correlation of GRACE risk score with the severity of coronary artery Disease in Non-STEMI but regarding the STEMI in predicting the severity of coronary artery disease, the available international data is limited. In addition to prognostic assessment, predicting the anatomical extension of coronary artery disease is potentially useful for clinical decision. Estimating the possible severity of CAD by these scores before performing coronary angiography may change the therapeutic decision and the timing or intensity of interventions. The aim of the present study is to evaluate the relationship between GRACE score and severity of coronary artery disease (CAD) angiographically evaluated by Gensini score in patients with STEMI. |