Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538534
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2020-05-31
Brief Title:
Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
Sponsor:
Pr Semir Nouira
Organization:
University of Monastir
Study Overview
Official Title:
Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Radial artery is the recommended route for percutaneous coronary intervention for it significantly reduces net adverse clinical events compared to the femoral approach The success of the radial approach is therefore of a paramount importance However radial artery spasm RAS remains one of the major limitations of transradial approach TRA and the most frequent cause of TRA failure Several recommendations has been issued to improve success rate when using the radial route
In the Tunisian difficult economic context the use of low end equipment the unavailability of nitroglycerine and calcium antagonist verapamil has led to the general feeling that RAS and TRA failure has subsequently increased
The standard and only used protocol by the Tunisian interventional cardiologist consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture therefore limiting the options to prevent RAS
Nicardipine is the only injectable calcium antagonist available in Tunisia Its spasmolytic action on radial artery has been well demonstrated when used in CABG However it has been very poorly investigated in trans radial percutaneous coronary intervention
Investigators believe that the concomitant use of nicardipine with isorbide might significantly reduce RAS and TRA failure when compared to isosorbide dinitrate only
In the Tunisian difficult economic context the use of low end equipment the unavailability of nitroglycerine and calcium antagonist verapamil has led to the general feeling that RAS and TRA failure has subsequently increased
The standard and only used protocol by the Tunisian interventional cardiologist consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture therefore limiting the options to prevent RAS
Nicardipine is the only injectable calcium antagonist available in Tunisia Its spasmolytic action on radial artery has been well demonstrated when used in CABG However it has been very poorly investigated in trans radial percutaneous coronary intervention
Investigators believe that the concomitant use of nicardipine with isorbide might significantly reduce RAS and TRA failure when compared to isosorbide dinitrate only
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None