| CTRI Number |
CTRI/2020/09/027517 [Registered on: 01/09/2020] Trial Registered Prospectively |
| Last Modified On: |
12/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of cardiac disease during COVID 19 pandemic and impact among cardiologist in Tamil Nadu |
|
Scientific Title of Study
|
COVID 19 and its impact on the management of patients with Acute Coronary Syndrome: A questionnaire based survey amongst Cardiologist in Tamil Nadu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3RF002 Version 1.0 dated 07/08/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T R Muralidharan |
| Designation |
Senior Consultant Cardiologist |
| Affiliation |
C3 Research Foundation |
| Address |
C3 Research Foundation,
Research Department,
Cardiology Division,
Room No:1,
No: 5/463, Valayapathi Salai,
J.J.Nagar, Mogappair East,
Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
9710493435 |
| Fax |
|
| Email |
c3imc@c3rf.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Nagendra Boopathy |
| Designation |
Senior Consultant Cardiologist |
| Affiliation |
C3 Research Foundation |
| Address |
C3 Research Foundation,
Research Department,
Cardiology Division,
Room No:1,
No: 5/463, Valayapathi Salai,
J.J.Nagar, Mogappair East,
Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
|
| Fax |
|
| Email |
pulse@c3rf.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Vinod Kumar |
| Designation |
Consultant Cardiologist |
| Affiliation |
C3 Research Foundation |
| Address |
C3 Research Foundation,
Research Department,
Cardiology Division,
Room No:1,
No: 5/463, Valayapathi Salai,
J.J.Nagar, Mogappair East,
Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
|
| Fax |
|
| Email |
vinodkumar@c3rf.com |
|
|
Source of Monetary or Material Support
|
| C3 Research Foundation,
No 5/463, Valayapathi Salai, J.J.Nagar, Mogappair East,Chennai -600037 |
|
|
Primary Sponsor
|
| Name |
C Research Foundation |
| Address |
No 5/463, Valayapathi Salai, J.J.Nagar, Mogappair East, Chennai - 600037 |
| 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 B Vinod Kumar |
C3 Research Foundation |
Research Department,
Cardiology Division,
Room No:1,
No 5/463, Valayapathi Salai, J.J.Nagar, Mogappair East, Chennai - 600037
Chennai
TAMIL NADU |
9710493435
vinodkumar@c3rf.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medstar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cardiologist |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the cardiologist who treat COVID patients |
|
| ExclusionCriteria |
| Details |
Other speciality doctors
Cardiologist who did not treat COVID patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the impact of COVID in managing patients with acute coronary syndrome |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of PCI done before COVID and after COVID |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/09/2020 |
| Date of Study Completion (India) |
25/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
COVID-19 disease, caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), has imposed an unprecedented burden on healthcare systems worldwide. While guidance on management of cardiovascular conditions in the setting of COVID-19 will be being gathered, little is known about the effects of the pandemic on interventional cardiology practice. The first reports originating from highly affected areas describe a reduction in the number of patients presenting to the emergency department (ED) with acute coronary syndromes (ACS). The survey done by Marco Roffi et al suggests that interventional cardiology practice has been disrupted in multiple aspects by the COVID-19 pandemic, ranging from cath lab personnel availability, to the need for personal protection, to the management of ACS patients and the massive reduction in procedural activity. In order to shed light on the impact of the COVID-19 pandemic on the management of patients encountered in routine interventional cardiology practice, C3 Research Foundation will be conducting a survey among the cardiologist in India |