Comparison of Radial and Ulnar Artery Intervention in Patients With ST Elevated Myocardial Infarction

Not Applicable

Completed

• Conditions: ST Elevated Myocardial Infarction
• Interventions: Procedure: primary percutaneous coronary intervention

• Registration Number: NCT04183140
• Lead Sponsor: Sakarya University

Brief Summary

In the literature, there are no studies comparing these two pathways in ST elevation myocardial infarction (STEMI). In this patient group, it will be investigated whether transulnar intervention causes similar or less complications than transradial intervention, and whether it provides superiority or similarity in terms of outcomes.

Detailed Description

The transulnar approach is known as an alternative procedure for transradial coronary angiography due to its safety and applicability. For cardiologists, experienced in trans-ulnar access, this access zone is comfortable to use. Because less spasm is developing. In addition, no significant difference was found between the transradial and transulnar routes in terms of other complications.In the literature, there are no studies comparing these two pathways in ST elevation myocardial infarction (STEMI). In this patient group, it will be investigated whether transulnar intervention causes similar or less complications than transradial intervention, and whether it provides superiority or similarity in terms of outcomes.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-03
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients over 18 years of age
• admitted for primary percutaneous intervention
• either of these two routes has not been used in the last week
• a sufficient pulse at both routes

Exclusion Criteria

• cardiogenic shock
• stent thrombosis
• the use of either of these two arteries in the last 1 week
• either of these arteries can not be pulsed or very weak pulsed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transradial	primary percutaneous coronary intervention	Transradial intervention
Transulnar	primary percutaneous coronary intervention	Transulnar intervention

Primary Outcome Measures

Name	Time	Method
Complication rate	1 day	Major and minor neurovascular events (access related) of the arm including pain/motor paralysis/paresthesia, hematoma, pseudoaneurysm, artery spasm, arterial occlusion
in-hospital cardiac outcomes	1 week	the incidence of death, myocardial infarction (MI), urgent target lesion revascularization (TLR), acute heart failure as major adverse cardiac events (MACEs) within the hospital

Trial Locations

Locations (1)

Sakarya University Education and Research Hospital; 🇹🇷 Sakarya, TR, Turkey