Predictive Value of Allen's Test Result in Elective Patients Undergoing Coronary Catheterization Through Radial Approach (RADAR)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
coronary catheterisation
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Allen's test, lactate, safety, radial intervention, Patients with coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- All patients undergoing coronary catheterisation through radial artery
Exclusion Criteria:
- Presence of haemodynamic instability
- Planned IABP insertion
- Previous trauma or surgical intervention in the instrumented arm
- Impossibility to obtain informed consent
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Patients with normal Allen's test
Patients with intermediate Allen's test
Patients with abnormal Allen's test
Outcomes
Primary Outcome Measures
elevation of thumb capillary lactate after the procedure
Secondary Outcome Measures
local discomfort, disability of the instrumented arm defined as perceived (subjective) or objective muscular weakness, need for surgical intervention or RA occlusion at any time within 30 days after catheterisation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00597324
Brief Title
Predictive Value of Allen's Test Result in Elective Patients Undergoing Coronary Catheterization Through Radial Approach
Acronym
RADAR
Official Title
Should Intervention Through RADial Approach be Denied to Patients With Negative Allen's Test Results?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Valgimigli
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will evaluate the feasibility and safety of radial approach in patients undergoing coronary catheterisation without any restrictions based on the results of Allen's test.
Detailed Description
The transfemoral access (TFA), through the percutaneous Seldinger technique, is the preferred approach in most catheterization laboratories worldwide due to its long history of use, the large availability of several dedicated preformed Judkins-type catheters and the possibility to exploit relatively large diameter catheters and sheaths, should these be necessary for complex percutaneous coronary intervention (PCI). Being a relatively deep and terminal vessel however, the femoral artery as percutaneous access site may expose to rare ischemic but frequent bleeding complications which occurs between 3-7% of patients undergoing interventional procedures, especially with modern anti-thrombotic drugs, including glycoprotein IIb/IIIa receptor blockers and clopidogrel. The difficulties in obtaining a stable and definitive local haemostasis, even when dedicated arterial vascular closure devices (VCD) are employed, make prolonged bed rest after TFA necessary in the majority of cases which result in patient discomfort and overall increase in medical expenditure.
In the last fifteen years, after Campeau's report of successful coronary angiography by transradial approach (TRA), the radial artery has been increasingly employed as an alternative access site both for diagnostic and interventional procedures.
The main advantage offered by percutaneous TRA is represented by the very low incidence of relevant vascular access site complications and bleeding and allows for early mobilization of the patient and thus to early discharge. As bleeding complications are increasingly recognized as strong and independent predictors of short and long-term outcomes following PCI, TRA may be the preferred access site by experienced teams. Radial artery (RA) cannulation, however, carries a risk of RA occlusion with an incidence of 4.8% to 19%. This is usually of no consequence, because the hand receives blood from both the radial and ulnar arteries (UA) with extensive collateral channels; however, some patients have incomplete palmar arches and might not have adequate communications between the ulnar and radial arteries. In these patients, there is a potential risk of hand ischemia in the event of RA occlusion.
A simple bedside test to check for communications between the ulnar and radial arteries is the modified Allen's test (AT). Patients with an abnormal test will usually have their cardiac catheterization performed via the femoral artery, thus denying them the potential advantages of transradial cardiac catheterization. In patients undergoing coronary angiography, the incidence of an abnormal AT ranges from 6.4% to 27%. Whether the AT can predict ischemic complications after RA cannulation is controversial, and some centers no longer exclude patients with an abnormal AT.
However, In 50 patients undergoing coronary angiography were screened for AT time. Circulation in the RA, UA, principal artery of the thumb (PAT), and thumb capillary lactate were measured before and after 30 min of RA occlusion. patients with an abnormal AT showed significantly reduced blood flow to the thumb and increased thumb capillary lactate (compared with patients with a normal AT) suggestive of ischemia. Based on these findings, Authors concluded that Transradial cardiac catheterization should not be performed in patients with an abnormal AT.
Aim of the RADAR study is to evaluate whether results of Allen's test in consecutive patients undergoing transradial coronary catheterization predict the occurrence of ischemic complications defined primarily as an increase of thumb capillary lactate and secondarily as a composite of local discomfort during and/or after the procedure, disability of the instrumented arm defined as perceived (subjective) or objective muscular weakness, need for surgical intervention or RA occlusion at any time within 30 days after catheterisation. Bleeding complications will be also monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Allen's test, lactate, safety, radial intervention, Patients with coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients with normal Allen's test
Arm Title
2
Arm Type
Experimental
Arm Description
Patients with intermediate Allen's test
Arm Title
3
Arm Type
Experimental
Arm Description
Patients with abnormal Allen's test
Intervention Type
Procedure
Intervention Name(s)
coronary catheterisation
Other Intervention Name(s)
Coronary angiography, PCI
Intervention Description
Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically
Primary Outcome Measure Information:
Title
elevation of thumb capillary lactate after the procedure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
local discomfort, disability of the instrumented arm defined as perceived (subjective) or objective muscular weakness, need for surgical intervention or RA occlusion at any time within 30 days after catheterisation.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients undergoing coronary catheterisation through radial artery
Exclusion Criteria:
Presence of haemodynamic instability
Planned IABP insertion
Previous trauma or surgical intervention in the instrumented arm
Impossibility to obtain informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Valgimigli, MD, PhD
Organizational Affiliation
Azienda Universitaria Ospedaliera di Ferrara, corso Giovecca 203; 44100; Ferrara; Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Ferrara
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24583305
Citation
Valgimigli M, Campo G, Penzo C, Tebaldi M, Biscaglia S, Ferrari R; RADAR Investigators. Transradial coronary catheterization and intervention across the whole spectrum of Allen test results. J Am Coll Cardiol. 2014 May 13;63(18):1833-41. doi: 10.1016/j.jacc.2013.12.043. Epub 2014 Feb 26.
Results Reference
derived
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Predictive Value of Allen's Test Result in Elective Patients Undergoing Coronary Catheterization Through Radial Approach
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