Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy (L-RECORD)
Primary Purpose
Coronary Artery Disease, Vascular Access Complication
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Coronary Angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring L-RECORD, Radial, Femoral, CABG, coronary artery bypass graft
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years
- Written informed consent
- Clinical indication for coronary angiography in a patient with prior history of CABG
- Left radial artery has not been used as a graft during CABG
Exclusion Criteria:
- Age over 90 years
- Patient's refusal to participate in the study
- Hemodynamic instability of the patient
- Failure to place a sheath at the randomization access site
- Arteriovenous fistula at the left upper limb
- Use of right internal mammary artery as a graft during CABG
- Creatinine clearance <30 ml/min
Sites / Locations
- University Hospital of Patras
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Left Radial access
Femoral access
Arm Description
Left Radial approach for coronary angiography in patients with prior history of CABG surgery
Femoral approach for coronary angiography in patients with prior history of CABG surgery
Outcomes
Primary Outcome Measures
Net Procedure Time
The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
Secondary Outcome Measures
Total Procedure Time
The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography
Fluoroscopy Time
Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
Dose Area Product
Radiation DAP (mGy*cm2) during the diagnostic coronary angiography
Contrast Volume
Contrast volume (ml) used during the diagnostic coronary angiography
Crossover access site
Need for crossover access site, other than this of randomization
Major Cardiovascular Events
Death, stroke, acute myocardial infarction
Vascular Complications
Vascular access complications
Full Information
NCT ID
NCT03393052
First Posted
December 31, 2017
Last Updated
June 3, 2018
Sponsor
University Hospital of Patras
Collaborators
Korgialenio-Benakio Red Cross Hospital, University General Hospital of Heraklion, AHEPA University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03393052
Brief Title
Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
Acronym
L-RECORD
Official Title
Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras
Collaborators
Korgialenio-Benakio Red Cross Hospital, University General Hospital of Heraklion, AHEPA University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.
Detailed Description
Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Vascular Access Complication
Keywords
L-RECORD, Radial, Femoral, CABG, coronary artery bypass graft
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Left Radial access
Arm Type
Active Comparator
Arm Description
Left Radial approach for coronary angiography in patients with prior history of CABG surgery
Arm Title
Femoral access
Arm Type
Active Comparator
Arm Description
Femoral approach for coronary angiography in patients with prior history of CABG surgery
Intervention Type
Procedure
Intervention Name(s)
Coronary Angiography
Intervention Description
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
Primary Outcome Measure Information:
Title
Net Procedure Time
Description
The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total Procedure Time
Description
The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography
Time Frame
24 hours
Title
Fluoroscopy Time
Description
Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
Time Frame
24 hours
Title
Dose Area Product
Description
Radiation DAP (mGy*cm2) during the diagnostic coronary angiography
Time Frame
24 hours
Title
Contrast Volume
Description
Contrast volume (ml) used during the diagnostic coronary angiography
Time Frame
24 hours
Title
Crossover access site
Description
Need for crossover access site, other than this of randomization
Time Frame
24 hours
Title
Major Cardiovascular Events
Description
Death, stroke, acute myocardial infarction
Time Frame
24 hours
Title
Vascular Complications
Description
Vascular access complications
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years
Written informed consent
Clinical indication for coronary angiography in a patient with prior history of CABG
Left radial artery has not been used as a graft during CABG
Exclusion Criteria:
Age over 90 years
Patient's refusal to participate in the study
Hemodynamic instability of the patient
Failure to place a sheath at the randomization access site
Arteriovenous fistula at the left upper limb
Use of right internal mammary artery as a graft during CABG
Creatinine clearance <30 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Hahalis, Prof.
Organizational Affiliation
University Hospital of Patras
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Periklis Davlouros, Ass. Prof.
Organizational Affiliation
University Hospital of Patras
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Grigorios Tsigkas
Organizational Affiliation
University Hospital of Patras
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Athanasios Makris
Organizational Affiliation
University Hospital of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Patras
City
Patras
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26210808
Citation
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Results Reference
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Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
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