Comparison of Vascular Access in STEMI

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT04941638
Collaborator
(none)
109
1
12
276.5

Study Details

Study Description

Brief Summary

Distal radial access (DRA) has recently introduced and previous studies have demonstrated that it is feasible option, showing several advantages including less bleeding and access-site complications over proximal radial access (PRA). Previous study reported the feasibility of DRA as an alternative option for primary percutaneous coronary intervention (PCI) in STEMI patients without major complication. However, comparison study of each vascular access for primary PCI have not been conducted until now. Here, The investigators aim to compare the DRA, PRA and femoral access (FA), in terms of feasibility and safety, in patients with STEMI.

This is a retrospective study with patients who underwent primary PCI for STEMI between March 2020 to May 2021. The primary outcome of this study is the access-site complication including major bleeding requiring transfusion or surgery, hematoma and arterial occlusion.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Distal radial access

Detailed Description

Recently, DRA has gained the interest of interventional cardiologists and previous studies have demonstrated several advantages including patient and operator comfort, shorter hemostasis duration, less bleeding, and access-site complications over PRA. More recently, randomized trial demonstrated that DRA prevents radial artery occlusion after the procedure compared with PRA. From this perspective, DRA could be considered an alternative access route for primary PCI in selected STEMI patients using potent P2Y12 inhibitors such as ticagrelor or prasugrel, or glycoprotein IIb/IIIa inhibitors.

Study Design

Study Type:
Observational
Actual Enrollment :
109 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Distal Radial, Proximal Radial and Femoral Access in ST-Segment Elevation Myocardial Infarction
Actual Study Start Date :
Jun 17, 2021
Actual Primary Completion Date :
Jun 22, 2021
Actual Study Completion Date :
Jun 29, 2021

Outcome Measures

Primary Outcome Measures

  1. access-site complication [1 month]

    puncture site related complication

Secondary Outcome Measures

  1. The success rate of the puncture [Through procedure]

    The success rate (%) of vascular puncture

  2. The success rate of the primary PCI [Through procedure]

    Success rate (%) = Successful primary PCI / All PCI procedures

  3. The percentage of puncture time in Door-to-wiring time (%) [Through procedure]

    Puncture time = time interval from local anesthesia induction to successful sheath cannulation. Door-to-wiring time = time elapsed from arrival of patient at the emergency department to guide wire passage through the lesion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Between March 2020 to May 2021, patients who underwent primary PCI for STEMI at the Yongin Severance Hospital
Exclusion Criteria:
  • Refractory cardiogenic shock requiring extracorporeal membrane oxygenation (ECMO)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yongin Severance Hospital Yongin Gyeonggi-do Korea, Republic of 16995

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Yongcheol Kim, Yongin Severance Hopistal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yongcheol Kim, Professor, Yonsei University
ClinicalTrials.gov Identifier:
NCT04941638
Other Study ID Numbers:
  • DRA-STEMI
First Posted:
Jun 28, 2021
Last Update Posted:
Apr 22, 2022
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yongcheol Kim, Professor, Yonsei University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022