| CTRI Number |
CTRI/2020/09/027613 [Registered on: 05/09/2020] Trial Registered Prospectively |
| Last Modified On: |
13/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Pattern of acute MI admissions in India during COVID-19 era: a Cardiological Society of India study
|
|
Scientific Title of Study
|
Pattern of acute MI admissions in India during COVID-19 era: a Cardiological Society of India study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geevar Zachariah |
| Designation |
Consultant Cardiologist |
| Affiliation |
Chairman, Mother Heart Care |
| Address |
PO N Pullazhi Rd Olarikkara Thrissur, Kerala
PANTHEON, REMADEVI MANDIR LANE
PUNKUNNAM, THRISSUR KERALA
680002
Thrissur
KERALA
680002
India |
| Phone |
914872380022 |
| Fax |
|
| Email |
geevarzachariah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geevar Zachariah |
| Designation |
Consultant Cardiologist |
| Affiliation |
Chairman, Mother Heart Care |
| Address |
PO N Pullazhi Rd Olarikkara Thrissur, Kerala
Pantheon, Remadevi Mandir Lane Punkunnam, Thrissur
Thrissur
KERALA
680012
India |
| Phone |
914872380022 |
| Fax |
|
| Email |
geevarzachariah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geevar Zachariah |
| Designation |
Consultant Cardiologist |
| Affiliation |
Chairman, Mother Heart Care |
| Address |
PO N Pullazhi Rd Olarikkara Thrissur, Kerala
PANTHEON, REMADEVI MANDIR LANE
PUNKUNNAM THRISSUR 680002
Thrissur
KERALA
680002
India |
| Phone |
914872380022 |
| Fax |
|
| Email |
geevarzachariah@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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurunath Parale |
Ashwini Sahakari Hospital |
Department of Cardiology,Ashwini Sahakari Hospital
North Sadar Bazaar, South Sadar Bazar, Jawaharlal Housing Society, Keshav Nagra, Solapur, Maharashtra 413003
Solapur
MAHARASHTRA |
02172319900
02172319982
ashwinihosp@yahoo.com |
| Dr Saket Joshi |
CK Birla Hospitals |
Department of Cardiology,Rukmani Birla Hospital,Gopalpura Bypass Road, Near Triveni Bridge,Gopalpura,Jaipur – 302018
Jaipur
RAJASTHAN |
01413090309
infomedical.rbh@ckbirlahospitals.com |
| Dr Ajaykumar Pandey |
Galaxy Hospital |
Department of Cardiology,Galaxy Hospital
Dayal Enclave, 4,5,6,7, Mahmoorganj Rd, Near Railway Station, Mahmoorganj, Varanasi, Uttar Pradesh 221010
Varanasi
UTTAR PRADESH |
05422221444
patient.care@galaxyhospitalvaranasi.com |
| Dr Jay Shah |
HCG Hospitals |
Department of Cardiology, HCG Hospitals
Mithakhali Six Road, Ellisbridge, Ahmedabad, Gujarat 380006
Ahmadabad
GUJARAT |
07940010101
07940010103
info.hms@hcghospitals.com |
| Dr Chirag Patel |
Kakkadiya hospital |
Department of Cardiology, Kakkadiya Multi Speciality Hospital, Sukh Sagar Complex,Lal Bahadur Shastri Rd, opp. Dinesh Chambers, Bapunagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
79-22205854
hospital_kakadiya@yahoo.com |
| Dr Praveen Shukla |
L.P.S. Institute Of Cardiology & Cardiac Excellence |
Department of Cardiology, L.P.S. Institute Of Cardiology& Cardiac Excellence
G.S.V.M Medical College, Swroop Nagar, G T Road,Rawatpur, Kanpur, Uttar Pradesh 208019
Kanpur Nagar
UTTAR PRADESH |
5122532269
5122547978
vinaycvtcs@gmail.com |
| Dr Jayagopal |
Lakshmi Hospital |
Cardiology Department,Lakshmi Hospital No. 17/751,
Chittur Road,Palakkad,
Kerala 678013, India
Palakkad
KERALA |
04912539999
lakshmihospitalpalakkad@gmail.com |
| Dr Madhu |
NIMS Medicity Trivandrum |
Department of Cardiology, NIMS Medicity
Aralummoodu, Neyyattinkara, Trivandrum 695123 Kerala
Thiruvananthapuram
KERALA |
04712222115
info@nimsmedicity.org |
| Dr Tarun |
Star Hospital |
Department of Cardiology,Star Hospital
near Indica Laboratories, Vadilal Park, Bapunagar, Ahmedabad, Gujarat 380024
Ahmadabad
GUJARAT |
07922201717
info@starhospital.org |
| Dr Anurag |
Tulip Multispeciality Hospital |
Department of Cardiology, Tulip Multispeciality Hospital T. P. Scheme, no.15, Delhi Rd, Vivekanand chowk, Sonipat, Haryana 131001
Sonipat
HARYANA |
7056511111
tuliphosp@gmail.com |
| Dr Sunil Thanvi |
Zydus Hospitals |
Department of Cardiology,Zydus Hospitals Road,
Nr. Sola Bridge, S.G. Highway,
Ahmedabad - 380054,
Gujarat, India.
Ahmadabad
GUJARAT |
07926800201
infoahd@zydushospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 115 |
| Name of Committee |
Approval Status |
| Ruby General Hospital |
Approved |
| AHMEDABAD INSTITUTE OF MEDICAL SCIENCES |
Approved |
| AIIMS New Delhi |
Approved |
| AMRI Hospital,Odisha |
Approved |
| Andhra hospital |
Approved |
| Apollo CVHFÂ Heart Institute |
Approved |
| Apollo Hospital,Odisha |
Approved |
| Apollo Hospital-02 |
Approved |
| APOLLO HOSPITALS |
Approved |
| Apollo Hospitals Guwahati |
Approved |
| Apple Hospital |
Approved |
| Appollo Glenegals Hospital Kolkata |
Approved |
| Ashwini Hospital |
Approved |
| Ashwini Sahakari Rugnalaya Ani Sanshodhan Kendra Nyt Solpaur |
Approved |
| Aswini Hospital |
Approved |
| Baby Memorial Hospital |
Approved |
| Bokaro General Hospital |
Approved |
| BR Kalinga Hospital, Odisha |
Approved |
| Brigesh Banger Memorial Hospital,Bhilwara |
Approved |
| Burdwan Medical College Bar |
Approved |
| C K Brila Hospital |
Approved |
| Capital Hospital, Odisha |
Approved |
| Caritas Hospital |
Approved |
| Cauvery heart & Multispeciality hospital |
Approved |
| CHL Hospital |
Approved |
| CIMS Hospital |
Approved |
| Columbia asia hospital Mysore |
Approved |
| Delhi Heart and Lung Institute |
Approved |
| Dispur Hospital Pvt. Ltd. |
Approved |
| Dr Ram Manohar Lohia Hospital New Delhi(RML) |
Approved |
| Dr Rameshcardiac and Multispeciality hospital |
Approved |
| Dr. sampurnanand Medical College, Jodpur |
Approved |
| Dr.Jivraj Mehta Hospital |
Approved |
| Eternal Heart Care Centre & Research Institute, Rajasthan |
Approved |
| Excelcare Hospital |
Approved |
| Father Muller Medical College |
Approved |
| Fortis Escorts Hospital |
Approved |
| Fortis Hospitals Limited Mumbai |
Approved |
| Galaxy Hospital |
Approved |
| GNRC Ltd. |
Approved |
| Guwahati MCH |
Approved |
| Hayat Hospital |
Approved |
| HCG Hospital |
Approved |
| Heart and General Hospital,Jaipur |
Approved |
| Hegde Medical College |
Approved |
| Help hospitals Private Limited |
Approved |
| HiTech Hospital Odisha |
Approved |
| Holy Family Hospital Mumbai |
Approved |
| IMS and Sum Hospital |
Approved |
| Indus hospital |
Approved |
| Inodaya hospital |
Approved |
| Kakkadiya Hospital |
Approved |
| Kamalnayan Bajaj Hospital Aurangabad |
Approved |
| Kasturba medical college |
Approved |
| KD HOSPITAL |
Approved |
| KEM Hospital |
Approved |
| KIMS -17 |
Approved |
| KIMS Hospital Odisha |
Approved |
| KIMS-07 |
Approved |
| King George Hospital |
Approved |
| Kollam District Hospital |
Approved |
| Lakshmi Hospital |
Approved |
| Leo Metro Hospital |
Approved |
| Life Care Hospital |
Approved |
| Lisie Hospital |
Approved |
| Little Flower Hospital and Research Centre |
Approved |
| LPS Institute |
Approved |
| M.O.S.C MEDICAL COLLEGE HOSPITAL |
Approved |
| Madras Medical Mission-01 |
Approved |
| Manipal Hospital |
Approved |
| Maulana Medical college and Associated Hospital New Delhi |
Approved |
| Max Super speciality Hospital, Saket |
Approved |
| Medanta Hospital |
Approved |
| Medica Superspeciality Hospital, Kolkata |
Approved |
| Meenakshi Mission Hospital-08 |
Approved |
| Metromed International Cardiac Center |
Approved |
| MIOT Hospital-06 |
Approved |
| MKCG Medical College,Odisha |
Approved |
| Moulana Hospital |
Approved |
| Nanjappa Hospital |
Approved |
| Narayana Health Rabindranath Tagore International Institute |
Approved |
| Narayana Multispeciality Hospital |
Approved |
| Narayana multuspeciality hospital |
Approved |
| NEIGRIMS Shilong |
Approved |
| Nemcare Hospital Pvt. Ltd. |
Approved |
| NIMS |
Approved |
| OMNI hospital |
Approved |
| PGIMS |
Approved |
| Pushpagiri Medical College Hospital |
Approved |
| R.G.Kar Medical College and Hospital, Kolkata |
Approved |
| Raj Artemis Hospital |
Approved |
| Ramakrishna Hospital-10 |
Approved |
| Rukmani Birla Hospital, Jaipur |
Approved |
| S.P Medical College, Bikaner |
Approved |
| SAL Hospital & Medical Institute |
Approved |
| Sanjeevini Hospital |
Approved |
| Santhiram Super Speciality hospital |
Approved |
| SCB Medical College & Hospital Odisha |
Approved |
| SGVP Holistic Hospital |
Approved |
| Shrikrishna Hrudayalaya And Critical Care Center |
Approved |
| Silchar Medical College & Hospital |
Approved |
| Sir Ganga Ram Hospital, New Delhi |
Approved |
| Sky Hospital & Research Centre Pvt. Ltd |
Approved |
| SMS Hospital, Rajasthan |
Approved |
| Sri Ramachandra Medical College |
Approved |
| Star Hospital |
Approved |
| Suyog Hospital |
Approved |
| The Gujarat Research & Medical Institute ( Rajasthan Hospital) |
Approved |
| Tripura Medical College |
Approved |
| Trust hospital |
Approved |
| Tulip Multispeciality Hospital |
Approved |
| Uttam Clinic |
Approved |
| Vijan Cardiac and Critical Care Centre |
Approved |
| Viswa Bharathi Super Speciality Hospital |
Approved |
| Zydus Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Acute Myocardial infraction |
|
| ExclusionCriteria |
| Details |
Any admissions other than for MI |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out change in the number of AMI admissions in major hospitals in India during the period from 15th of March to 15th of June 2020 (COVID-19 era) compared to corresponding period in 2019. And to find out weekly AMI admissions during the period from 15th of March to 15th of June 2020, in different parts of India and to assess the impact of various phases of lockdown and its relaxations in AMI admissions. |
The period from 15th of March
to 15th of June 2020 (COVID-19 era) compared to corresponding period in 2019. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out mortality rate of AMI patients admitted to major hospitals in India during the COVID-19 era compared to corresponding period in 2019. |
The period from 15th of March to 15th of June 2020 (COVID-19 era) compared to corresponding period in 2019. |
To find out type of AMI (STEMI vs NSTEMI), rate of coronary angiography and PTCA,
rate of PCI, thrombolysis or no revascularization and time windowsfor STEMI, and rate of major complications for AMI in India during COVID-19 era compared to corresponding period in 2019. |
The period from 15th of March to 15th of June 2020 (COVID-19 era) compared to corresponding period in 2019. |
|
|
Target Sample Size
|
Total Sample Size="30000"
Sample Size from India="30000"
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)
|
15/09/2020 |
| 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="0"
Months="1"
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 will tell us how COVID-19 pandemic has impacted AMI care in India.
If the number of AMI admissions has come down, but mortality has gone up and time windows show delay compared to previous year, it means people with AMI are not
coming to the hospital either due to fear of getting infected with COVID or
due to lack of transport facility.Based on the study, we will be able to provide suitable recommendations to the government regarding
the need to inform the public by print and visual media that more people die due to AMI than COVID and it is important to seek
emergency cardiac care for AMI. If the study shows that cardiologists prefer to anlyse patients with STEMI ratherthan do primary PTCA (possibly due to fear
of getting infected) and that increases inhospital mortality, we will be able to issue appropriate guidelines regarding STEMI management during COVID era. |