Predictive Value of Allen's Test Result in Elective Patients Undergoing Coronary Catheterization Through Radial Approach (RADAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT00597324
First received: December 26, 2007
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: coronary catheterisation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Should Intervention Through RADial Approach be Denied to Patients With Negative Allen's Test Results?

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • elevation of thumb capillary lactate after the procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 203
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients with normal Allen's test
Procedure: coronary catheterisation
Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically
Other Names:
  • Coronary angiography
  • PCI
Experimental: 2
Patients with intermediate Allen's test
Procedure: coronary catheterisation
Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically
Other Names:
  • Coronary angiography
  • PCI
Experimental: 3
Patients with abnormal Allen's test
Procedure: coronary catheterisation
Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically
Other Names:
  • Coronary angiography
  • PCI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597324

Locations
Italy
University Hospital
Ferrara, FE, Italy, 44100
Sponsors and Collaborators
Marco Valgimigli
Investigators
Principal Investigator: Marco Valgimigli, MD, PhD Azienda Universitaria Ospedaliera di Ferrara, corso Giovecca 203; 44100; Ferrara; Italy
  More Information

No publications provided by Università degli Studi di Ferrara

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Valgimigli, Head of the Catheterization laboratory, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT00597324     History of Changes
Other Study ID Numbers: RAD-1-MV
Study First Received: December 26, 2007
Last Updated: October 26, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
Allen's test
lactate
safety
radial intervention
Patients with coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014