Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction

July 30, 2015 updated by: Buxing Chen, Capital Medical University
Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety of left radial approach for primary PCI in STEMI patients compared with right radial approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary PCI.

Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be excluded if they are in cardiogenic shock.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing,, China, 100050
        • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All consecutive patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset for primary PCI.

Exclusion Criteria:

Patients are excluded if they were in cardiogenic shock.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Right radial approach
Primary PCI performed through right radial approach.
Procedure: Left radial approach
Primary PCI performed through left radial approach.
Experimental: Left radial approach
Primary PCI performed through left radial approach.
Procedure: Right radial approach
Primary PCI performed through right radial approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Needle to balloon time
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation dose
Time Frame: 7 days
Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)
7 days
Fluoroscopy time
Time Frame: 7 days
7 days
Contrast volume
Time Frame: 7 days
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular complications
Time Frame: 7 days
Vascular complications include pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Principal Investigator: Buxing Chen, MD, Ph.D, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 3, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lerrasmi (Registry Identifier: Lerrasmi)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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