| CTRI Number |
CTRI/2023/11/059574 [Registered on: 06/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An artificial intelligence based study to evaluate the association between Covid infection or vaccination on heart diseases |
|
Scientific Title of Study
|
Influence of Covid-19 infection and vaccination on coronary artery disease and its risk factors: An artificial intelligence based study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghavendra U |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Instrumentation and Control Engineering
Manipal Institute of technology
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9008052848 |
| Fax |
|
| Email |
raghavendra.u@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra U |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Instrumentation and Control Engineering
Manipal Institute of technology
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9008052848 |
| Fax |
|
| Email |
raghavendra.u@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra U |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Instrumentation and Control Engineering
Manipal Institute of technology
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9008052848 |
| Fax |
|
| Email |
raghavendra.u@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room No 36
3rd Floor OPD Block
Department of Cardiology
Kasturba Medical College
Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Dr Raghavendra U |
| Address |
Department of ICE
Manipal Institute of Technology
Manipal Academy of Higher Education |
| 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 |
| Dr Raghavendra U |
Kasturba Hospital |
Room No 36
3rd Floor
OPD Bolck
Department of Cardiology
Kasturba hospital Manipal
Udupi
KARNATAKA |
9008052848
raghavendra.u@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hopsital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I70||Atherosclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18 years and above (have been vaccinated or not)
Participants who are undergoing coronary angiogram at the Department of Cardiology Kasturba Hospital Manipal
Able to read write and converse in English/Kannada
|
|
| ExclusionCriteria |
| Details |
Participants who are not willing to give consent
Patients with congenital heart disease
Patients with known genetic diseases and related cardiomyopathies
Patients with rheumatic heart diseases
Patients with major psychiatric disorders, dementia or delirium.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of Coronary Artery Disease
Risk factors for Coronary artery disease
Determinants of Coronary artery disease |
At the recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Treadmil stress test findings
CT angio results
Left ventrcular function |
At the recruitment |
|
|
Target Sample Size
|
Total Sample Size="1800"
Sample Size from India="1800"
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)
|
13/11/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After IEC clearance and CTRI
registration, this prospective observational study will be conducted. Patients
who are undergoing coronary angiogram and who meet the inclusion criteria will
be included in this study. Informed consent will be obtained prior to the
recruitment. Brief details of the patient’s demographic and clinical history
are obtained. This includes age, gender, weight, height, and comorbidity
history related to cardiovascular diseases. Further, a brief history is taken
regarding COVID 19- infection and vaccination details. COVID-19 infection is
confirmed based on verbal communication however, the severity of COVID-19
infection will be assessed based on documented evidence if any. If the
participant does not know the vaccination details himself/herself, we intend to
contact his/her relative personally, if not, telephonically to gather the
information on COVID 19- infection and vaccination status. Blood test reports
such as complete lipid profile, Hb, NT-Pro BNP, Troponin T, D-Dimer, CRP values
are documented if present. Further, a few parameters are obtained from ECG,
Treadmill stress test (TMT), Chest X-Ray, Echocardiogram, and CT-coronary
angiogram if performed in them. These parameters include ST-T changes in ECG,
test results of TMT, Ejection fraction and abnormal findings of the
echocardiographic test, Heart failure changes in chest X-Ray, and Coronary
calcium score from CT. All the parameters and data that are extracted are drawn
from the tests that are routinely performed among patients undergoing coronary
angiogram tests as a part of standard care. Meanwhile, Gensini score and Syntax
scores are used in the severity assessment of the coronary artery using
coronary angiogram. In addition, blood test parameters, ECG, Echo, TMT, CT and
CAG parameters during COVID infection or before the COVID-19 era are also
documented if available. A copy of 12 lead ECGs, Chest X-Ray images, Apical 4
chamber images from stored Echocardiographic data, and coronary angiogram
recording will be taken for the creation of an automated diagnostic model.
|