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

Comparation of Transulnar Versus Transradial Approach for Primary Percutaneous Coronary Intervention in Patients With ST-elevated Myocardial Infarction in Terms of Procedure Complications and In-hospital Cardiac Outcomes

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 Overview

• Status: Completed
• Conditions: ST Elevated Myocardial Infarction
• Intervention / Treatment: Procedure: primary percutaneous coronary intervention

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • TR
    • Sakarya, TR, Turkey, 54100
      • Sakarya University Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transradial; Transradial intervention	Procedure: primary percutaneous coronary intervention; primary percutaneous coronary intervention via transulnar or transradial access
Active Comparator: Transulnar; Transulnar intervention	Procedure: primary percutaneous coronary intervention; primary percutaneous coronary intervention via transulnar or transradial access

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sakarya University
• Investigators: Principal Investigator: Kahraman Cosansu, Sakarya University

Publications and helpful links

General Publications

• Roghani-Dehkordi F, Mansouri R, Khosravi A, Mahaki B, Akbarzadeh M, Kermani-Alghoraishi M. Transulnar versus transradial approach for coronary angiography and angioplasty: Considering their complications. ARYA Atheroscler. 2018 May;14(3):128-131. doi: 10.22122/arya.v14i3.1586.
• Bi X, Wang Q, Liu D, Gan Q, Liu L. Is the Complication Rate of Ulnar and Radial Approaches for Coronary Artery Intervention the Same? Angiology. 2017 Nov;68(10):919-925. doi: 10.1177/0003319717703226. Epub 2017 Apr 7.
• Dahal K, Rijal J, Lee J, Korr KS, Azrin M. Transulnar versus transradial access for coronary angiography or percutaneous coronary intervention: A meta-analysis of randomized controlled trials. Catheter Cardiovasc Interv. 2016 Apr;87(5):857-65. doi: 10.1002/ccd.26221. Epub 2015 Sep 2.
• Geng W, Fu X, Gu X, Jiang Y, Fan W, Wang Y, Li W, Xing K, Liu C. Safety and feasibility of transulnar versus transradial artery approach for coronary catheterization in non-selective patients. Chin Med J (Engl). 2014;127(7):1222-8.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Complication; Radial Artery; Ulnar Artery; Primary Percutaneus Coronary Intervention
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: SEAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No