| CTRI Number |
CTRI/2022/04/041778 [Registered on: 11/04/2022] Trial Registered Prospectively |
| Last Modified On: |
10/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mucormycosis related cardiovascular changes study |
|
Scientific Title of Study
|
To study incidence and evolution of cardiovascular changes in Mucor mycosis infection at a tertiary care centre in North India |
| 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 |
Associate Professor |
| Affiliation |
All India Institute of Medical Science Bathinda |
| Address |
Department of Cardiology , All India Institute of Medical Science , Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Walia |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science Bathinda |
| Address |
Department of Cardiology , All India Institute of Medical Science , Bathinda
PUNJAB
151001
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Walia |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science Bathinda |
| Address |
Department of Cardiology , All India Institute of Medical Science , Bathinda
PUNJAB
151001
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science Bathinda , Punjab |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science Bathinda |
| Address |
Dabwali Road ,Lal Singh Nagar , Bathinda , Punjab |
| Type of Sponsor |
Government medical college |
|
|
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 Rohit Walia |
All india Institute of Medical Science Bathinda |
Department of Cardiology
Bathinda
PUNJAB |
8800492549
rwalia7731@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Science Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B49||Unspecified mycosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
age greater than 18 years
nucor cases reporting to cardiology out patient department
valid informed consent |
|
| ExclusionCriteria |
| Details |
not giving consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total cardiovascular events in the group |
4 weeks after presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of acute myocardial events in Mucormycosis population 
at baseline and during hospital stay |
30 days |
| Myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponin elevation and echocardiography |
30 days post hospital admission |
| Characterization of inflammation on cardio-vascular outcomes |
30 days post hospital admission |
| New onset cardiac arrhythmia |
30 days post hospital admission |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/04/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Mucormycosis is an invasive fungal infection . In immunocompromised patients they cause vascular invasion and infarction of organs. Cardiac involvement in the form of myocarditis, angio invasive mucormycosis causing acute coronary syndrome has been reported. We planned an observational study to find out incidence and range of cardiovascular involvement in mucormycosis patients. We take both retrospective and prospective data. We do baseline ECG , echocardiography , cardiac biomarkers and follow them up for 3 months post hospitalisation. We look for any cardiovascular involvement , acute coronary syndrome , arrhythmias during hospitalisation and follow up. |