search
Back to results

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

Primary Purpose

ST Elevated Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
primary percutaneous coronary intervention
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ST Elevated Myocardial Infarction focused on measuring Complication, Primary Percutaneus Coronary Intervention, Radial Artery, Ulnar Artery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sakarya University Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transradial

Transulnar

Arm Description

Transradial intervention

Transulnar intervention

Outcomes

Primary Outcome Measures

Complication rate
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
the incidence of death, myocardial infarction (MI), urgent target lesion revascularization (TLR), acute heart failure as major adverse cardiac events (MACEs) within the hospital

Secondary Outcome Measures

Full Information

First Posted
November 15, 2019
Last Updated
October 25, 2022
Sponsor
Sakarya University
search

1. Study Identification

Unique Protocol Identification Number
NCT04183140
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevated Myocardial Infarction
Keywords
Complication, Primary Percutaneus Coronary Intervention, Radial Artery, Ulnar Artery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transradial
Arm Type
Active Comparator
Arm Description
Transradial intervention
Arm Title
Transulnar
Arm Type
Active Comparator
Arm Description
Transulnar intervention
Intervention Type
Procedure
Intervention Name(s)
primary percutaneous coronary intervention
Intervention Description
primary percutaneous coronary intervention via transulnar or transradial access
Primary Outcome Measure Information:
Title
Complication rate
Description
Major and minor neurovascular events (access related) of the arm including pain/motor paralysis/paresthesia, hematoma, pseudoaneurysm, artery spasm, arterial occlusion
Time Frame
1 day
Title
in-hospital cardiac outcomes
Description
the incidence of death, myocardial infarction (MI), urgent target lesion revascularization (TLR), acute heart failure as major adverse cardiac events (MACEs) within the hospital
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kahraman Cosansu
Organizational Affiliation
Sakarya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sakarya University Education and Research Hospital
City
Sakarya
State/Province
TR
ZIP/Postal Code
54100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30349575
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.
Results Reference
background
PubMed Identifier
28387125
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.
Results Reference
background
PubMed Identifier
26332022
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.
Results Reference
background
PubMed Identifier
24709170
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs