Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization

NCT ID: NCT03993834

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-25

Study Completion Date

2021-07-01

Brief Summary

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Transradial access (TRA) is commonly used in different medical fields due to the superficial position of the radial artery and related advantages. Despite its popularity, the incidence and importance of related complications, in particular, radial artery occlusion (RAO) remains unclear. Further, the only known independent predictors of the radial artery occlusion are the periprocedural anticoagulation as well as the catheter size. The effect of a variable arterial anatomy has so far not been evaluated.

In this context, most institutions prefer to evaluate the collateral circulation of the hand, i.e., the arterial palmar arch and forearm circulation before TRA. The most commonly employed tests are the modified Allen test (MAT) or the combination of pulse oximetry and plethysmography according to Barbeau.In addition, there are more precise, but still semi-quantitative non-invasive methods for palmar arterial collateral function testing.

Despite the wealth of these variably accurate and practical tests, invasive and direct hemodynamic measurement of the arterial forearm circulation and its components is lacking. Thus, the human physiologic circulatory reference at this site has been unknown so far. Further, the need of pre-procedural testing itself can be questioned in light of the reported, widely varying prevalence of RAO (1-38%) or critical ischemia (0-0.09%) after TRA.

The present study investigated in a first step the invasively obtained, pressure-derived hemodynamic function, i.e., the physiology of the human arterial palmar arch and forearm collateral circulation and in a second step the clinical consequences of the variable palmar arterial anatomy.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal modified Allen Test

Patients undergoing transradial coronary angiography with a modified Allen-Test ≤ 15 seconds

No interventions assigned to this group

Abnormal modified Allen Test

Patients undergoing transradial coronary angiography with a modified Allen-Test \> 15 seconds

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Patient receiving transradial coronary angiography and undergoing evaluation of the palmar arterial arch circulation as a quality control
* Written informed consent to participate in the follow-up Doppler ultrasound examination

Exclusion Criteria

* Changed anatomical conditions of the radial artery, e.g. after coronary artery bypass surgery with radial harvest
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Seiler, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern University Hospital

Locations

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University Hospital Inselspital, Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Bigler MR, Buffle E, Rappo MV, Grossenbacher R, Tschannen C, Seiler C. Association of Palmar Arch Collateral Function and Radial Artery Occlusion After Transradial Access. Am J Cardiol. 2022 Apr 1;168:151-158. doi: 10.1016/j.amjcard.2021.12.020. Epub 2022 Jan 20.

Reference Type DERIVED
PMID: 35065801 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/21470671

Jolly SS et al. Lancet 2011 - Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.

Other Identifiers

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2017-00622

Identifier Type: -

Identifier Source: org_study_id

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