Clinical trial NCT04183140: Comparison of Radial and Ulnar Artery Intervention in Patients With ST Elevated Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Elevated Myocardial Infarction
Keywords: Complication
Primary Percutaneus Coronary Intervention
Radial Artery
Ulnar Artery
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate
timeFrame: 1 day
measure: in-hospital cardiac outcomes
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Education and Research Hospital
state: TR
Study officials:
affiliation: Sakarya University
name: Kahraman Cosansu
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.