| CTRI Number |
CTRI/2019/07/020002 [Registered on: 02/07/2019] Trial Registered Prospectively |
| Last Modified On: |
28/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Left Thumb Artery as the route for Coronary Angiography and Angioplasty |
|
Scientific Title of Study
|
Vasant Kunj Left dIstal Transradial artEry(ldTRA)approach(VKLITE) study |
| Trial Acronym |
VKLITE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tapan Ghose |
| Designation |
Director and Head of cardiology |
| Affiliation |
Fortis Flt Lt Rajan Dhall Hospital |
| Address |
Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
South West
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
ghosetapan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapan Ghose |
| Designation |
Director and head of cardiology |
| Affiliation |
Fortis Flt Lt Rajan Dhall Hospital |
| Address |
Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
South West
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
ghosetapan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tapan Ghose |
| Designation |
Director and head department of cardiology |
| Affiliation |
Fortis Flt Lt Rajan Dhall Hospital |
| Address |
Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
South West
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
ghosetapan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Tapan Ghose Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
Patient
Insurance/TPA |
|
|
Primary Sponsor
|
| Name |
Dr Tapan Ghose |
| Address |
Room No 12 OPD Basement Fortis Flt Lt Rajan Dhall Hospital Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Tapan Ghose |
Fortis Flt Lt Rajan Dhall Hospital |
Room No 12 OPD Basement Sector B Pocket1 Aruna Asaf Ali Marg Vasant Kunj
South West
DELHI |
9811695113
42776221
ghosetapan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21||Acute myocardial infarction, (2) ICD-10 Condition: I20||Angina pectoris, (3) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (4) ICD-10 Condition: I237||Postinfarction angina, (5) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are 20 years and older requiring coronary angiography
Patients who are palpable left distal radial artery
Patients who agree to participate in the study |
|
| ExclusionCriteria |
| Details |
patients who are positive in modified Allens test
Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The frequency of success rate of coronary angiography% and percutaneous coronary intervention% |
At the end of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success rate of puncture
diameter of distal radial artery
Hemostasis duration
Complications
procedure time
Radiation dose and time
Patients satisfaction score |
At the end of procedure and during hospital stay |
|
|
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)
|
10/07/2019 |
| 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 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)?
|
|
Brief Summary
|
We have been using radial artery as an approach in coronary interventions for last 12 years . Recently left distal radial artery has been used as a route for coronary angiography and angioplasty. This has an advantage to the patient .The loss of radial pulse does not occur. Radial artery is available for future CABG and AV fistula creation in renal patients should the need arise in future. We decided to perform this study for the left distal radial approach feasibility ,safety and efficacy in our patients so that we can give this advantage to Indian patients.
|