Predictive Value of Allen's Test Result in Elective Patients Undergoing Coronary Catheterization Through Radial Approach
RADAR
Should Intervention Through RADial Approach be Denied to Patients With Negative Allen's Test Results?
1 other identifier
interventional
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 coronary-artery-disease
Started Oct 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedOctober 27, 2011
October 1, 2011
1.7 years
December 26, 2007
October 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
elevation of thumb capillary lactate after the procedure
30 days
Secondary Outcomes (1)
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.
30 days
Study Arms (3)
1
ACTIVE COMPARATORPatients with normal Allen's test
2
EXPERIMENTALPatients with intermediate Allen's test
3
EXPERIMENTALPatients with abnormal Allen's test
Interventions
Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically
Eligibility Criteria
You may qualify if:
- All patients undergoing coronary catheterisation through radial artery
You may not qualify if:
- Presence of haemodynamic instability
- Planned IABP insertion
- Previous trauma or surgical intervention in the instrumented arm
- Impossibility to obtain informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marco Valgimiglilead
Study Sites (1)
University Hospital
Ferrara, FE, 44100, Italy
Related Publications (1)
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.
PMID: 24583305DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Valgimigli, MD, PhD
Azienda Universitaria Ospedaliera di Ferrara, corso Giovecca 203; 44100; Ferrara; Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of the Catheterization laboratory
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 18, 2008
Study Start
October 1, 2007
Primary Completion
June 1, 2009
Study Completion
August 1, 2010
Last Updated
October 27, 2011
Record last verified: 2011-10