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

ST Elevated Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183140
• Other study ID #: SEAH
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevated Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• primary percutaneous coronary intervention
primary percutaneous coronary intervention via transulnar or transradial access

Locations

Country	Name	City	State
Turkey	Sakarya University Education and Research Hospital	Sakarya	TR

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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