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

NCT ID: NCT04183140

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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ST Elevated Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Transradial

Transradial intervention

Group Type ACTIVE_COMPARATOR

primary percutaneous coronary intervention

Intervention Type PROCEDURE

primary percutaneous coronary intervention via transulnar or transradial access

Transulnar

Transulnar intervention

Group Type ACTIVE_COMPARATOR

primary percutaneous coronary intervention

Intervention Type PROCEDURE

primary percutaneous coronary intervention via transulnar or transradial access

Interventions

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primary percutaneous coronary intervention

primary percutaneous coronary intervention via transulnar or transradial access

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Kahraman Cosansu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kahraman Cosansu

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

Locations

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Sakarya University Education and Research Hospital

Sakarya, TR, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30349575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28387125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26332022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24709170 (View on PubMed)

Other Identifiers

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SEAH

Identifier Type: -

Identifier Source: org_study_id

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