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

Not Applicable

Completed

• Conditions: Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction
• Interventions: Procedure: Left radial approach; Procedure: Right radial approach

• Registration Number: NCT02239757
• Lead Sponsor: Capital Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2013-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right radial approach	Left radial approach	Primary PCI performed through right radial approach.
Left radial approach	Right radial approach	Primary PCI performed through left radial approach.

Primary Outcome Measures

Name	Time	Method
Needle to balloon time	1 day

Secondary Outcome Measures

Name	Time	Method
Radiation dose	7 days	Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)
Fluoroscopy time	7 days
Contrast volume	7 days

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing,, China