| CTRI Number |
CTRI/2020/12/029981 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to look for cardiovascular manifestations of COVID |
|
Scientific Title of Study
|
To study cardiovascular involvement in COVID 19 patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science Rishikesh |
| Address |
Room No. 25103 , Department of cardiology , All India Institute of Medical Science , Virbhadra Road , Pashulok , Rishikesh .
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic |
| Affiliation |
All India Institute of Medical Science Rishikesh |
| Address |
Room No. 25103 , Department of cardiology , All India Institute of Medical Science , Virbhadra Road , Pashulok , Rishikesh .
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science Rishikesh |
| Address |
Room No. 25103 , Department of cardiology , All India Institute of Medical Science , Virbhadra Road , Pashulok , Rishikesh .
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science Rishikesh |
|
|
Primary Sponsor
|
| Name |
Rohit Walia |
| Address |
Room number 25103 , Department of Cardiology , All India Institute of Medical Science Rishikesh |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Rohit Walia |
All India Institute of Medical Science Rishieksh |
Room number 25103, Department of Cardiology
Dehradun
UTTARANCHAL |
8800492549
rwalia7731@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Science Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with COVID 19 disease confirmed by RTPCR
Age greater than 18 years |
|
| ExclusionCriteria |
| Details |
Not giving informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of acute myocardial events in COVID-19 population at baseline
and during hospital stay |
Incidence of acute myocardial events in COVID-19 population at baseline
and during hospital stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiovascular outcomes : myocardial infarction or stenosis, stroke, pulmonary embolism, deep vein thrombosis, ventricular dysfunction, conduction disorders and sudden death |
14 days till hospitalisation |
| New-onset cardiac arrhythmia |
14 days since hospitalisation |
| To evaluate the reversibility or progression of cardiac involvement at 2 months of follow up vs. at discharge time |
2 months |
|
|
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)
|
28/12/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID patients have cardiovascular involvement in around 20 percent of cases but exact extent of involvement and course of involvement and reversibility of cardiovascular changes over 2 months of follow up is not known. We plan this study to study frequency , progression and reversibility of cardiovascular involvement over 2 months. |