| CTRI Number |
CTRI/2022/09/045880 [Registered on: 26/09/2022] Trial Registered Prospectively |
| Last Modified On: |
02/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Case Control Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
assessment of global longitudinal strain echocardiography and brachial artery flow-mediated dilatation in patients of ANCA associated vasculitis |
|
Scientific Title of Study
|
“A prospective case control study to evaluate the cardiovascular functions by global longitudinal strain (GLS) echocardiography and brachial artery flow mediated dilatation in patients with ANCA associated vasculitis†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VIkram Kala |
| Designation |
Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Level 3, Block C, room no 3002 Department of cardiology, Advanced Cardiac Centre, PGIMER, Sector 12, Chandigarh, 160012.
Level 3, Block C, room no 3002 Department of cardiology, Advanced Cardiac Centre, PGIMER, Sector 12, Chandigarh, 160012.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drvikram83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Vijayvergiya |
| Designation |
Professor of Cardiology |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Room No 3002, 3rd floor, C block, Department of cardiology, Advanced Cardiac Centre, PGIMER, Sector 12, Chandigarh, 160012.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815221856 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Vijayvergiya |
| Designation |
Professor of Cardiology |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Room No 3002, 3rd floor, C block, Department of cardiology, Advanced Cardiac Centre, PGIMER, Sector 12, Chandigarh, 160012.
CHANDIGARH
160012
India |
| Phone |
9815221856 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology, Advanced Cardiac Centre, PGIMER, Sector 12, Chandigarh, 160012. |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of Cardiology, Advanced Cardiac Centre, PGIMER, Sector 12, Chandigarh, 160012. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vikram Kala |
PGIMER Chandigarh |
Department of cardiology, Advanced Cardiac Centre, PGIMER, Sector 12, Chandigarh, 160012.
Chandigarh
CHANDIGARH |
8059666690
drvikram83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M318||Other specified necrotizing vasculopathies, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18 and 70 years of age, previously diagnosed cases of ANCA associated vasculitis, who have been in remission for more than 06 months, will be included in the study group. 2. Age and sex-matched healthy controls will be included the control group 3. Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect. |
|
| ExclusionCriteria |
| Details |
1. Patients with clinical instability with compromised hemodynamics including (not restricted to)
a. Symptomatic decompensated heart failure
b. Renal failure requiring renal replacement therapy
c. Shock due to any cause
2. Patients with a medical condition that limits the life expectancy to less than one year
3. Women who are pregnant or planning to be pregnant
4. Patients with history of Diabetes mellitus
5. Patients with history of smoking
6. Patients with history of premature CAD in a first degree relative (in men aged 45 years, in women aged 55 years)
7. Patients with history of sildenafil use
8. Patients with history of peripheral vascular disease
9. Patients who are ineligible for the study in the opinion of the investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Left ventricular systolic functions assessment by global longitudinal strain 2D speckle tracking echocardiography.
2) Endothelial dysfunction assessment Flow & nitroglycerine mediated dilatation of brachial artery assessment. |
will be assessed at the time of scan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Left ventricular systolic functions with flow & nitroglycerine mediated dilation of brachial artery |
will be assess at the Time of scan. |
|
|
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)
|
30/09/2022 |
| 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="1"
Months="0"
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 is a case controlled non randomised single centre active controlled study to evaluate the cardiovascular functions by global longitudinal strain (GLS) echocardiography and to evaluate endothelial dysfunction by brachial artery flow and nitroglycerine mediated dilatation in patients with ANCA associated vasculitis. The study is being conducted at PGIMER Chandigarh. Primary outcomes of the study are (1) Left ventricular systolic functions assessment by global longitudinal strain 2D speckle tracking echocardiography and (2) Endothelial dysfunction assessment Flow & nitroglycerine mediated dilatation of brachial artery assessment. |