CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2021/03/031757 [Registered on: 08/03/2021] Trial Registered Prospectively

Last Modified On:

04/06/2021

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

COVID 19 Infected ST-Elevation Myocardial Infarction in INDIA (COSTA INDIA) - A Cardiological Society of India Study

Scientific Title of Study

COVID 19 Infected ST-Elevation Myocardial lnfarction in INDIA (COSTA INDIA)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Jabir Abdullakutty
Designation	Senior Consultant Cardiologist
Affiliation	Director of Academic Affairs and Clinical Research
Address	Lisie Heart Institute, Lisie Hospital, Kacheripady PO, Ernakulam Ernakulam KERALA 682018 India
Phone	9447011773
Fax
Email	costaindia2020@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Jabir Abdullakutty
Designation	Senior Consultant Cardiologist
Affiliation	Director of Academic Affairs and Clinical Research
Address	Lisie Heart Institute, Lisie Hospital, Kacheripady PO, Ernakulam Ernakulam KERALA 682018 India
Phone	9447011773
Fax
Email	costaindia2020@gmail.com

Details of Contact Person
Public Query

Name	Dr Jabir Abdullakutty
Designation	Senior Consultant Cardiologist
Affiliation	Director of Academic Affairs and Clinical Research
Address	Lisie Heart Institute, Lisie Hospital, Kacheripady PO, Ernakulam Ernakulam KERALA 682018 India
Phone	9447011773
Fax
Email	costaindia2020@gmail.com

Source of Monetary or Material Support

Cardiological Society of India P-60, C.I.T ROAD, SCHEME -VII-M KANKURGACHI, KOLKATA - 700054, INDIA

Primary Sponsor

Name	Cardiological Society of India
Address	P-60, C.I.T ROAD, SCHEME VII-M, KANKURGACHI, KOLKATA - 700054, INDIA
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 4
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Bavesh Vajifdar	Lilavati Hospital and Research Center	A791, Bandra Reclamation, Bandra West, Mumbai 400050 Mumbai MAHARASHTRA	022-26568000 bvajifdar@hotmail.com
Dr Shilpa Kadam	Mahatma Gandhi Mission Medical College	Sector 18, Kamothe, Kalamboli, Navi Mumbai Raigarh MAHARASHTRA	022-27433404 shilpakadam.dr@gmail.com
Dr Girish MP	Maulana Azad Medical College and Associated Hospital	2-Bahadur Shah Zafar Marg, New Delhi New Delhi DELHI	9891117573 mpgirish_1999@yahoo.com
Dr Dilip Kumar	Medica Superspecialty Hospital	127, Mukundapur, EM Byepass, Kolkata 700099 Kolkata WEST BENGAL	9748487563 dilipcardio@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 17
Name of Committee	Approval Status
Bhaikaka University	Approved
CIMS	Approved
G Kuppuswamy Naidu Memorial Hospital	Approved
Galaxy Hospital	Approved
Heart and General Hospital	Approved
Holy Family Hospital	Approved
JNM Medical College	Approved
Kasturba Hospital	Approved
Lilavati Hospital and Research Center	Approved
Mahatma Gadhi Mission Medical College	Approved
Maulana Azad Medical College	Approved
Medica Superspeciality Hospital	Approved
NHRTIICS Ethics Committee	Approved
S C B Medical College	Approved
SMS Medical College	Approved
Sri Jayadeva Ethics Committee	Approved
Tripura Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I229\|\|Subsequent ST elevation (STEMI) myocardial infarction of unspecified site,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	19.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	All consecutive patients above the age of 18 years with STEMI or with new LBBB on 12 lead ECG and diagnosed as acute myocardial infarction (MI) as per the fourth universal definition of MI and COVID-19 positive. The cases could be STEMI patients shown to be COVID-19 positive during routine screening after admission or referred from elsewhere as COVID positive or STEMI developing in the hospital after admission for treatment of COVID 19 infection. COVID-19 infection should be confirmed with RTPCR / Truenat / CBnat / rapid antigen test. Age and sex-matched STEMI patients who are COVID negative will be enrolled as the control group for comparison in a 2:1 ratio.

ExclusionCriteria

Details

patients below the age of 18 years
Patients with STEMI who are COVID-19 negative

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

1.To find out differences in the composite of in-hospital mortality, heart failure, shock, stroke and systemic embolizations in COVID-19 infected STEMI patients compared to age and sex-matched non-infected STEMI patients treated during the same period.
2. To find out changes in the management strategies of COVID-infected STEMI patients compared to non-infected age and sex-matched STEMI controls treated during the same period.

This nationwide retrospective observational study on the clinical presentation, clinical course, and in-hospital outcomes of COVID-infected STEMI patients admitted during the period May 1st, 2020 to December 31 st, 2020.

Secondary Outcome

Outcome	TimePoints
1. In-hospital mortality in COVID 19 infected STEMI patients 2. Incidence of stroke or systemic embolization in COVID infected STEMI patients 3. Incidence of heart failure in COVID 19 infected STEMI patients. 4. Frequency of use of mechanical ventilation COVID 19 infected STEMI cases 5. Incidence of ARDS in COVID 19 infected STEMI cases.	This is a multicentric retrospective cross-sectional study of all consecutive COVID-19 infected STEMI patients admitted during the period May 1st, 2020 to, December 31st 2020 in selected hospitals across India.

Target Sample Size

Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "1134"
Final Enrollment numbers achieved (India)="1134"

Phase of Trial

N/A

Date of First Enrollment (India)

10/03/2021

Date of Study Completion (India)

31/05/2021

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="1"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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 is a multicentric retrospective cross-sectional study of all consecutive COVID-19 infected STEMI patients admitted during the period May 1^st, 2020 to, December 31^st 2020 in selected hospitals across India. 40 -50 hospitals that have treated at least five COVID-19 infected STEMI patients will be identified. The hospitals should have proper medical record systems to enable retrieval of data like demography, co-morbid conditions, clinical presentation, medical treatment, reperfusion methods, presentation, clinical course and, management of COVID-19 infection along with outcomes of STEMI. They should also be able to provide the data of patients with age and sex-matched COVID-19 free STEMI patients treated in the same period for the control arm. The comparator population will be age and sex-matched COVID-19 free STEMI patients treated during the same time period in a two to one ratio. Categorical variables will be reported as frequencies and percentages. Continuous variables will be expressed as mean and standard deviation. Clinical and demographic variables will be reported using mean +/- SD or as median when appropriate. Continuous and categorical variables will be assessed using appropriate tests and P-value >.05 will be considered statistically significant.