| CTRI Number |
CTRI/2024/07/070635 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
STUDY OF SUBCUTANEOUS NITROGLYCERINE INFILTRATION FOR TRANS-RADIAL ACCESS IN IMPROVING THE SUCCESS RATE AND REDUCING EARLY RADIAL ARTERY BLOCKAGE |
|
Scientific Title of Study
|
Evaluating the efficacy of subcutaneous nitroglycerine infiltration for trans radial access in improving the success rate and reducing early radial artery occlusion. A randomised double blind placebo controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ISHFAQ GULZAR BHAT |
| Designation |
DM RESIDENT |
| Affiliation |
J N Medical College, AMU , Aligarh , UP |
| Address |
DEPARTMENT OF CARDIOLOGY
JAWAHARLAL NEHRU MEDICAL COLLEGE,
ALIGARH MUSLIM UNIVERSITY (AMU)
ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7006123734 |
| Fax |
|
| Email |
Ishfaqgulzar419@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Rafi Anwar |
| Designation |
Associate Professor |
| Affiliation |
J N Medical College, AMU , Aligarh (UP) |
| Address |
DEPARTMENT OF CARDIOLOGY
JAWAHARLAL NEHRU MEDICAL COLLEGE,
ALIGARH MUSLIM UNIVERSITY (AMU)
ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8171386851 |
| Fax |
|
| Email |
drmranwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ishfaq Gulzar Bhat |
| Designation |
DM Resident |
| Affiliation |
J N Medical College, AMU , Aligarh (UP) |
| Address |
DEPARTMENT OF CARDIOLOGY
JAWAHARLAL NEHRU MEDICAL COLLEGE,
ALIGARH MUSLIM UNIVERSITY (AMU)
ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7006123734 |
| Fax |
|
| Email |
ishfaqgulzar419@gmail.com |
|
|
Source of Monetary or Material Support
|
| J N Medical College AMU District Aligarh
PIN code : 202002
Uttar Pradesh, INDIA. |
|
|
Primary Sponsor
|
| Name |
JN Medical College AMU Aligarh |
| Address |
Department of Cardiology
Jawaharlal Nehru Medical College,Aligarh Muslim University, Aligarh-202002 |
| 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 Mohammad Rafi Anwar |
J N Medical College |
Cath Lab , Department of Cardiology, Aligarh Muslim University, Aligarh-202002
Aligarh
UTTAR PRADESH |
8171386851
drmranwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of J N Medical College AMU Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Subcutaneous injection during trans radial catheterisation
Dose: 0.5 ml Normal Saline
Duration: injection will be given at the time of procedure as bolus
Frequency: one dose |
| Intervention |
Nitroglycerine |
Subcutaneous injection during trans radial catheterisation
Dose : 150 mcg
Duration : injection will be given at the time of puncture as bolus
Frequency: one dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.giving written informed consent.
2.Patients undergoing diagnostic or therapeutic coronary catheterization via trans-radial approach
|
|
| ExclusionCriteria |
| Details |
1. Patients with inadequate blood supply to hand (negative Allen test)
2. Hemodynamic instability
3. Peripheral arterial disease
4. Raynauds phenomenon
5. Single Hand |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in success rate of Trans radial access with the use of subcutaneous nitroglycerine
2. Prevention of Early radial artery occlusion with the use of subcutaneous nitroglycerine |
From procedure to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Local complications
2. Vascular complications |
From procedure to 24 hours |
|
|
Target Sample Size
|
Total Sample Size="344"
Sample Size from India="344"
Final Enrollment numbers achieved (Total)= "345"
Final Enrollment numbers achieved (India)="345" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
30/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Transradial coronary catheterization is widely used as both diagnostic and interventional procedure for acute as well as chronic coronary syndromes. However, the access to radial artery is difficult due to spasm and also leads to radial artery occlusion. This study will evaluate the efficacy of subcutaneous Nitroglycerine Infiltration in improving the success rate and reducing early Radial Artery Occlusion using the Anterior Wall Puncture Technique for Radial Artery Access. This is a Randomized, Double-Blind, Placebo-Controlled Trial |