Back to resultsLeft vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
Primary Purpose
Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Left radial approach
Right radial approach
Sponsored by
About this trial
This is an interventional treatment trial for Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction focused on measuring Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction
Eligibility Criteria
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.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Right radial approach
Left radial approach
Arm Description
Primary PCI performed through right radial approach.
Primary PCI performed through left radial approach.
Outcomes
Primary Outcome Measures
Needle to balloon time
Secondary Outcome Measures
Radiation dose
Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)
Fluoroscopy time
Contrast volume
Full Information
NCT ID
NCT02239757
First Posted
September 11, 2014
Last Updated
July 30, 2015
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02239757
Brief Title
Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction
Keywords
Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right radial approach
Arm Type
Experimental
Arm Description
Primary PCI performed through right radial approach.
Arm Title
Left radial approach
Arm Type
Experimental
Arm Description
Primary PCI performed through left radial approach.
Intervention Type
Procedure
Intervention Name(s)
Left radial approach
Intervention Description
Primary PCI performed through left radial approach.
Intervention Type
Procedure
Intervention Name(s)
Right radial approach
Intervention Description
Primary PCI performed through right radial approach.
Primary Outcome Measure Information:
Title
Needle to balloon time
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Radiation dose
Description
Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)
Time Frame
7 days
Title
Fluoroscopy time
Time Frame
7 days
Title
Contrast volume
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Vascular complications
Description
Vascular complications include pseudoaneurysm, arteriovenous fistula, lose of radial artery pulse, puncture site bleeding and forearm hematoma.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buxing Chen, MD, Ph.D
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing,
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25018624
Citation
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.
Results Reference
background
Learn more about this trial
Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
We'll reach out to this number within 24 hrs