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Coronary Artery DiseasePhase 3RADARNCT00597324

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

A Phase 3 study testing coronary catheterisation in people with Coronary Artery Disease, run by Marco Valgimigli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
coronary catheterisation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteItaly
Study dates
Oct 2007to Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients undergoing coronary catheterisation through radial artery

Who cannot join

  • Presence of haemodynamic instability
  • Planned IABP insertion
  • Previous trauma or surgical intervention in the instrumented arm
  • Impossibility to obtain informed consent

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University Hospital

    Ferrara, FE, 44100

Other trials in Italy

About this study

Official title: Should Intervention Through RADial Approach be Denied to Patients With Negative Allen's Test Results?

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.

Read the 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.

Being tested
coronary catheterisation
Keywords
Allen's test, lactate, safety, radial intervention, Patients with coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • coronary catheterisationProcedure or surgery

    Also called Coronary angiography, PCI

    Coronary angiography which may be followed by ad hoc percutaneous intervention if indicated clinically

Study groups in NCT00597324
Study groupRoleWhat they receive
1Active comparatorPatients with normal Allen's test
Receives: Procedure: coronary catheterisation
2ExperimentalPatients with intermediate Allen's test
Receives: Procedure: coronary catheterisation
3ExperimentalPatients with abnormal Allen's test
Receives: Procedure: coronary catheterisation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. elevation of thumb capillary lactate after the procedure

    Measured: 30 days

Secondary outcomes (1)
  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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJun 2009
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597324
Sponsor's protocol ID
RAD-1-MV
Acronym
RADAR
Status last verified
Oct 2011
First submitted
26 Dec 2007
Last updated
27 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24583305

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing coronary catheterisation in people with Coronary Artery Disease, run by Marco Valgimigli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

elevation of thumb capillary lactate after the procedure (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00597324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011.

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