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

Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239757
• Other study ID #: LERRASMI
• Secondary ID: Lerrasmi
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: July 30, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: September 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Institutional Review Board of Beijing Tiantan Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction

Intervention

Procedure:
• Left radial approach
Primary PCI performed through left radial approach.
• Right radial approach
Primary PCI performed through right radial approach.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing,

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Hu H, Fu Q, Chen W, Wang D, Hua X, Chen B. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations. Clin Interv Aging. 2014 Jun 20;9:963-8. doi: 10.2147/CIA.S64235. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vascular complications	Vascular complications include pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.	7 days	Yes
Primary	Needle to balloon time		1 day	Yes
Secondary	Radiation dose	Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)	7 days	Yes
Secondary	Fluoroscopy time		7 days	Yes
Secondary	Contrast volume		7 days	Yes