CARDIAC CATHETRIZATIONNCT03182530
Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization
A study testing ulnar artery compression device, radial artery compression device guided with plysthmography and radial artery compression device in people with CARDIAC CATHETRIZATION, run by Assiut University.
Trial summary
Data from literature: transradial access failure sometimes occurs due to inability to cannulate the radial artery due to radial artery spasm1 causing severe difficulties in manipulation of the guide wires and catheters along the tortuous pathways of the arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CARDIAC CATHETRIZATION
- What is being tested?
- ulnar artery compression device, radial artery compression device guided with plysthmography and radial artery compression device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Mar 2019
- Phase
- Interventional
- 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
- Normal radial artery and of size ≥ 2mm by duplex.
- Normal ulnar artery by duplex.
Who cannot join
- Pre-procedural duplex detection of radial artery anomalies as hypoplasia, tortousity, severe calcification or radial artery diameter < 2 mm.
- Severe renal failure (creatinine clearance < 30 ml/min).
- Known peripheral vascular disease.
- Emergency procedures.
- Failure to successfully cannulate the radial artery was also a criterion for exclusion.
- Patients on warfarin therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization. Randomized Duplex Follow-up Study.
Data from literature: transradial access failure sometimes occurs due to inability to cannulate the radial artery due to radial artery spasm1 causing severe difficulties in manipulation of the guide wires and catheters along the tortuous pathways of the arteries. both mechanical stimuli and circulating catecholamines through activation of α1-adrenoreceptors, causing smooth muscle cell contraction \& radial artery spasm
- Conditions
- CARDIAC CATHETRIZATION
- Being tested
- ulnar artery compression device, radial artery compression device guided with plysthmography, radial artery compression device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulnar artery compression deviceDevice
a radial compression device will be applied at the access site. another closure device will be used for ipsilateral ulnar artery compression for 1-hour duration in order to increase peak velocity blood flow into the radi¬al artery. neither pulse oxymetry nor duplex ultrasonography will be performed in case of ulnar artery compression. after ulnar artery compression, the initial compression of the radial artery will be reduced by letting up the pressure until bleeding will be seen and then adding minimal pressure whenever needed in order to maintain radial artery patency.
radial artery compression device guided with plysthmographyDevice
a radial compression device will be applied at the access site. A pulse oximeter sensor was placed over the index finger. Transient ipsilateral ulnar artery will be occluded manually to evaluate the status of radial artery patency by plethysmography (digital pulse analysis), and if there's lack of signal, the process of deflation and reinflation of the radial artery device's bladder will be repeated over the next 15 min to attempt re-establishment of antegrade radial artery flow without affecting hemostasis
radial artery compression deviceDevice
patients undergo the conventional hemostasis compression by using a radial compression device applied at the access site.
| Study group | Role | What they receive |
|---|---|---|
| ULTRA method group | Active comparator | Not described Receives: Device: ulnar artery compression device; Device: radial artery compression device |
| standard patent hemostasis group | Active comparator | Not described Receives: Device: radial artery compression device guided with plysthmography |
| control group | Experimental | Not described Receives: Device: radial artery compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of occurrence of radial artery occlusion
the assessment will be done after compression device removal guided by duplex post trans-radial cardiac catheterization.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CARDIAC CATHETRIZATIONStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abbas Abdelaal, Assiut University
- Investigators
- Tarek nagib, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182530
- Sponsor's protocol ID
- PRCC
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization. Randomized Duplex Follow-up Study.
- ClinicalTrials.gov ID
- NCT03182530
- Acronym / sponsor ID
- PRCC
- Conditions
- CARDIAC CATHETRIZATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 9 Jun 2017 (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.
Data from literature: transradial access failure sometimes occurs due to inability to cannulate the radial artery due to radial artery spasm1 causing severe difficulties in manipulation of the guide wires and catheters along the tortuous pathways of the arteries. both mechanical stimuli and circulating catecholamines through activation of α1-adrenoreceptors, causing smooth muscle cell contraction \& radial artery spasm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ULTRA method group | Active comparator | Device: ulnar artery compression device, Device: radial artery compression device |
| standard patent hemostasis group | Active comparator | Device: radial artery compression device guided with plysthmography |
| control group | Experimental | Device: radial artery compression device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal radial artery and of size ≥ 2mm by duplex.
- Normal ulnar artery by duplex.
Key exclusion criteria (6 listed)
- Pre-procedural duplex detection of radial artery anomalies as hypoplasia, tortousity, severe calcification or radial artery diameter < 2 mm.
- Severe renal failure (creatinine clearance < 30 ml/min).
- Known peripheral vascular disease.
- Emergency procedures.
- Failure to successfully cannulate the radial artery was also a criterion for exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulnar artery compression devicea radial compression device will be applied at the access site. another closure device will be used for ipsilateral ulnar artery compression for 1-hour duration in order to increase peak velocity blood flow into the radi¬al artery. neither pulse oxymetry nor duplex ultrasonography will be performed in case of ulnar artery compression. after ulnar artery compression, the initial compression of the radial artery will be reduced by letting up the pressure until bleeding will be seen and then adding minimal pressure whenever needed in order to maintain radial artery patency. | Device | ULTRA method group |
| radial artery compression device guided with plysthmographya radial compression device will be applied at the access site. A pulse oximeter sensor was placed over the index finger. Transient ipsilateral ulnar artery will be occluded manually to evaluate the status of radial artery patency by plethysmography (digital pulse analysis), and if there's lack of signal, the process of deflation and reinflation of the radial artery device's bladder will be repeated over the next 15 min to attempt re-establishment of antegrade radial artery flow without affecting hemostasis | Device | standard patent hemostasis group |
| radial artery compression devicepatients undergo the conventional hemostasis compression by using a radial compression device applied at the access site. | Device | ULTRA method group, control group |
Primary outcome
The percentage of occurrence of radial artery occlusion
Time frame: 1 hour
the assessment will be done after compression device removal guided by duplex post trans-radial cardiac catheterization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Tarek nagib, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing ulnar artery compression device, radial artery compression device guided with plysthmography and radial artery compression device in people with CARDIAC CATHETRIZATION, run by Assiut University.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salwa dimitry, MD (00201223971267, salwademitry@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of occurrence of radial artery occlusion (time frame: 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 9 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.