| CTRI Number |
CTRI/2021/07/035295 [Registered on: 30/07/2021] Trial Registered Prospectively |
| Last Modified On: |
07/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective registry of STEMI management in Covid era -INDIA (PRESCO-INDIA) - A Cardiological Society of India Study |
|
Scientific Title of Study
|
Prospective registry of STEMI management in Covid era -INDIA (PRESCO-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 Padhinhare P Mohanan |
| Designation |
Sr. Consultant Cardiologist |
| Affiliation |
Director, Westfort Hi- Tech Hospital |
| Address |
Room No- 111, Westfort Hi-Tech Hospital,Punkunnam PO, Thrissur, Kerala
Thrissur
KERALA
680002
India |
| Phone |
9846076006 |
| Fax |
|
| Email |
csiamistudy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padhinhare P Mohanan |
| Designation |
Sr. Consultant Cardiologist |
| Affiliation |
Director, Westfort Hi- Tech Hospital |
| Address |
Room No- 111, Westfort Hi-Tech Hospital,Punkunnam PO, Thrissur, Kerala
Thrissur
KERALA
680002
India |
| Phone |
9846076006 |
| Fax |
|
| Email |
csiamistudy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padhinhare P Mohanan |
| Designation |
Sr. Consultant Cardiologist |
| Affiliation |
Director, Westfort Hi- Tech Hospital |
| Address |
Room No - 111, Westfort Hi-Tech Hospital,Punkunnam PO, Thrissur, Kerala
Thrissur
KERALA
680002
India |
| Phone |
9846076006 |
| Fax |
|
| Email |
csiamistudy@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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr L Sridhar |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Bannerghatta Road, Jayanagar, 9th Block,
Bangalore 560069
Bangalore
KARNATAKA |
08022977395
crc.jayadeva@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 29 |
| Name of Committee |
Approval Status |
| Apollo Hospital, Hyderabad |
Approved |
| Billroth Hospital, Chennai |
Approved |
| CIMS, Ahmedabad |
Approved |
| CK Birla Hospitals, Kolkata |
Approved |
| Coimbatore Medical College, Coimbatore |
Approved |
| Eternal Heart Care Center & Research Institute, Jaipur |
Approved |
| Excelcare Hospitals, Guwahati |
Approved |
| G. Kuppuswamy Naidu Memorial Hospital, Coimbathore |
Approved |
| Galaxy Hospital, Varanasi |
Approved |
| IGIMS, Patna |
Approved |
| Kasturba Hospital, Manipal |
Approved |
| King Georges Medical University, Lucknow |
Approved |
| Kishori Ram Hospital and Diabetes Care Centre, Bathinda, Punjab |
Approved |
| Maulana Azad Medical College and Associated Hospital, New Delhi |
Approved |
| Medica Superspecialty Hospital, Kolkata |
Approved |
| Moulana Hospital, Perintalmanna |
Approved |
| NHRTIICS, Kolkata |
Approved |
| North Eastern Indira Gandhi Regional Institute of Health and Medical Science, Shillong |
Approved |
| Osmania Medical College, Hyderabad |
Approved |
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana |
Approved |
| Pt. Jawahar Lal Nehru Memorial Medical College, Raipur |
Approved |
| Rajendra Institute of Medical Sciences, Ranchi |
Approved |
| RG Kar Medical College, Kolkata |
Approved |
| Shri Guru Ram Rai Institute of Medical & Health Sciences, Dehradun |
Approved |
| Sri Jayadeva Institute Ethics Committee |
Approved |
| Sri Jayadeva Institute of Cardiovascular sciences & Research, Mysore |
Approved |
| Sunshine Hospitals, Secunderabad |
Approved |
| The Mahatma Gandhi Mission Medical College, Mumbai |
Approved |
| Yashoda Hospital, Secunderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I20||Angina pectoris, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients above 18 years of age with STEMI as per 4thuniversal definition of MI during the study period |
|
| ExclusionCriteria |
| Details |
Patients below 18 years,
Patients not willing to give informed consent, Patients with life-threatening diseases like severe COVID 19 infection on ventilator,
Terminal malignancy,
Debilitating stroke and CKD patients on maintenance haemodialysis,
MI/PCI/CABG within past 14 days of STEMI admission,
Patients thrombolysed elsewhere,
Patients enrolled in any other research studies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the initial treatment strategy employed for hospitalized patients with STEMI in India during the current COVID-19 pandemic and to document the differences in the primary outcome of death, re-infarction and stroke in-hospital and at 30 days post discharge based on the initial treatment strategy. |
5 months or when target of 3000 patients are recruited which ever happens first |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the major in-hospital complications of STEMI patients in relation to the initial reperfusion strategy employed.
To study the differences in left ventricular function(LVEF) assessed by echocardiography during hospital admission and at 30 days post discharge among STEMI patients treated with various reperfusion strategies.
To study the time delay in the presentation of STEMI and the various reperfusion strategies employed.
|
5 months or when target of 3000 patients are recruited which ever happens first |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
09/08/2021 |
| 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="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prospective study will help
to identify the initial treatment strategies employed during COVID-19 pandemic
in India. The study will also evaluate the patient outcomes with lysis followed
by a delayed PCI strategy often widely employed in India. The
demographics, presentation patterns, major complications and in-hospital
outcomes would be analysed. Multivariate analysis on factors leading to outcomes
will be carried out. Finally, the use of guidelines based medications in the country
in STEMI management would also be assessed. This is the first and
largest prospective study on STEMI on presentation and management of STEMI in
India during COVID times and will provide insights into the STEMI management in
the country and the outcomes.
|