Ischemic Heart DiseaseACCESS-IVNCT05365282
Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
An observational study of Ischemic Heart Disease and Nerve Injury, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
Evaluation of potential nerve damage after radial CAG/PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Nerve Injury, Carpal Tunnel Syndrome
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients suspected of ischemic heart disease scheduled for radial CAG/PCI at Aarhus University Hospital
Who may be able to join
- The patient must be able to give informed consent
Who cannot join
- Pregnancy
- Negative Barbeau test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of cardiology, Aarhus University Hospital in Skejby
Aarhus, 8200
Christian J Terkelsen, MD,PhD
About this study
Official title: Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study - The ACCESS IV Study
Evaluation of potential nerve damage after radial CAG/PCI.
Read the detailed description
Prospective patients scheduled for radial CAG/ PCI will be enrolled in the study. Prior to the procedure, sensory and motor nerve examination is performed at the wrists in both arms / hands. The examination is performed on both the median nerve and the ulnar nerve. Each patient acts as their own control. The nerve test is repeated bilaterally 1 month after the procedure. This creates 2 groups, A and B.
Patients will be asked to complete 2 questionnaires in relation to hand and arm symptoms. The patients ability to perform certain activities before and after the CAG/PCI procedure are also addressed. In addition, a diagnostic tool (Katz chart) will be completed, also before and after the CAG/PCI procedure.
Hypothesis:
Radial access is associated with an increased risk of pain and an increased incidence of nerve damage similar to the median nerve at the carpal tunnel or the ulnar nerve at the Guyon's canal.
- Conditions
- Ischemic Heart Disease, Nerve Injury, Carpal Tunnel Syndrome
- Keywords
- Transradial access, Ischemic Heart Disease, Hand Dysfunction
- Medical subject headings
- Myocardial Ischemia, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Access pathway a. radialis (right or left) and neurophysiological measurements of the same hand (ipsilateral intervention group). | |
| Group B | Access pathway a.radialis (right or left) and neurophysiological measurements of opposite hand (contralateral intervention group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological measurements
The primary aim is the incidence/presence of electrofysiological signs of median and/or ulnar nerve lesion at the wrist and the presence of carpaltunnel syndrom.
The electrodiagnosis of carpaltunnelsyndrom will be determined from the clinical picture and signs of prolonged distal motor lantency and reduced motor and sensory nerveconduction velocity across the wrist and/or reduced amplitudes of the median nerve and normal ulnar nerve at the wrist.
Measured: Aprox 1 hour
Secondary outcomes (2)
Severity of hand symptoms and hand dysfunction
Boston questionaire
Measured: 10min
Severity of hand symptoms and hand dysfunction
QuickDash questionaire
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jan 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Juhl Terkelsen, Aarhus University Hospital Skejby
- Investigators
- Christian J Terkelsen, Professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365282
- Sponsor's protocol ID
- 1-10-72-177-20
- Acronym
- ACCESS-IV
- Status last verified
- Apr 2026
- First submitted
- 4 May 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study - The ACCESS IV Study
- ClinicalTrials.gov ID
- NCT05365282
- Acronym / sponsor ID
- ACCESS-IV / 1-10-72-177-20
- Conditions
- Ischemic Heart Disease, Nerve Injury, Carpal Tunnel Syndrome
- Keywords
- Transradial access, Ischemic Heart Disease, Hand Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of potential nerve damage after radial CAG/PCI.
Detailed description
Prospective patients scheduled for radial CAG/ PCI will be enrolled in the study. Prior to the procedure, sensory and motor nerve examination is performed at the wrists in both arms / hands. The examination is performed on both the median nerve and the ulnar nerve. Each patient acts as their own control. The nerve test is repeated bilaterally 1 month after the procedure. This creates 2 groups, A and B.
Patients will be asked to complete 2 questionnaires in relation to hand and arm symptoms. The patients ability to perform certain activities before and after the CAG/PCI procedure are also addressed. In addition, a diagnostic tool (Katz chart) will be completed, also before and after the CAG/PCI procedure.
Hypothesis:
Radial access is associated with an increased risk of pain and an increased incidence of nerve damage similar to the median nerve at the carpal tunnel or the ulnar nerve at the Guyon's canal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Access pathway a. radialis (right or left) and neurophysiological measurements of the same hand (ipsilateral intervention group). |
| Group B | – | –Access pathway a.radialis (right or left) and neurophysiological measurements of opposite hand (contralateral intervention group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of ischemic heart disease scheduled for radial CAG/PCI at Aarhus University Hospital
Key inclusion criteria (1 listed)
- The patient must be able to give informed consent
Key exclusion criteria (2 listed)
- Pregnancy
- Negative Barbeau test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurophysiological measurements
Time frame: Aprox 1 hour
The primary aim is the incidence/presence of electrofysiological signs of median and/or ulnar nerve lesion at the wrist and the presence of carpaltunnel syndrom. The electrodiagnosis of carpaltunnelsyndrom will be determined from the clinical picture and signs of prolonged distal motor lantency and reduced motor and sensory nerveconduction velocity across the wrist and/or reduced amplitudes of the median nerve and normal ulnar nerve at the wrist.
2 secondary outcomes
Severity of hand symptoms and hand dysfunction
Time frame: 10min
Severity of hand symptoms and hand dysfunction
Time frame: 10 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian J Terkelsen, Professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Nerve Injury, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 2 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 Denmark. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christel G Aagren Nielsen (+45 78452213, chisnils@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurophysiological measurements (time frame: Aprox 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.