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

NCT04183140 | Completed DMC

• 1 other identifier: SEAH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevated Myocardial Infarction

Keywords

Complication; Primary Percutaneus Coronary Intervention; Radial Artery; Ulnar Artery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Transradial

ACTIVE COMPARATOR

Transradial intervention

Procedure: primary percutaneous coronary intervention

Transulnar

ACTIVE COMPARATOR

Transulnar intervention

Procedure: primary percutaneous coronary intervention

Interventions

primary percutaneous coronary intervention PROCEDURE

primary percutaneous coronary intervention via transulnar or transradial access

Transradial; Transulnar

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Education and Research Hospital

Sakarya, TR, 54100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 30349575 BACKGROUND

• 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.

  PMID: 28387125 BACKGROUND

• 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.

  PMID: 26332022 BACKGROUND

• 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.

  PMID: 24709170 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Kahraman Cosansu

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients admitted with STEMI at the cardiology department and admitted to the catheter laboratory for primary percutaneous coronary intervention will be included in the study. There will be two groups in the study.In the first group, patients treated with transulnar access will be included. In the second group, patients using transradial access will be included. Patients will be treated by the same operator respectively. Peri-procedural data and in-hospital cardiac outcome data of patients in both groups will be recorded.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: December 3, 2019
• Study Start: November 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)