Myocardial IschemiaRadialHUSNCT05364463
Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation (RadialHUS)
A study testing Methods for cannulating the radial artery in a cardiac catheterization in people with Myocardial Ischemia and Cardiac Catheterization, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Aims: to evaluate the success rate of radial artery cannulation in patients undergoing cardiac catheterization, using different methods such as palpation, hyperemia or ultrasound-guided puncture, together or each method separately. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia, Cardiac Catheterization
- What is being tested?
- Methods for cannulating the radial artery in a cardiac catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2022to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years of age
- understand, accept and sign the informed consent
- participants undergoing radial artery cannulation for a diagnostic, therapeutic, or structural interventional cardiology procedure
- patent radial artery in the previous ultrasound evaluation
Who cannot join
- systolic blood pressure greater than 150mmHg
- diagnosis of acute myocardial infarction (with or without ST-segment elevation)
- previous surgeries that have affected the arterial system of the upper limbs (arteriovenous fistula, radial artery for bypass surgery, etc.)
- language barrier that hinders a clear study understanding for potential participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on the Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation in Patients Undergoing Cardiac Catheterization
Aims: to evaluate the success rate of radial artery cannulation in patients undergoing cardiac catheterization, using different methods such as palpation, hyperemia or ultrasound-guided puncture, together or each method separately. Specifically, the success rate at the first attempt, the number of attempts with each technique and the time spent will be assessed.
The hypothesis is that there are different success rates for each puncture technique when cannulating radial artery for cardiac catheterization.
Read more
Methods: randomized clinical trial with four parallel groups, with operator blinding. Those patients who will have the radial artery cannulated for an interventional cardiology procedure will be selected.
Once the participant agrees to be included in the study and signs the informed consent, they are randomized to one of four groups: ultrasound and hyperemia puncture, only ultrasound puncture, only hyperemia puncture, palpation puncture (control group). Subsequently, an ultrasound assessment of the participant's radial artery (diameter, depth and systolic peak velocity) will be performed. Once in the intervention room, the puncture will be performed according to the corresponding method. The puncturing operator in charge will not perform the randomization or the ultrasound assessment to avoid bias.
Variables will be collected in an ad hoc questionnaire designed to respond all study aims. Regarding the sample size, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 92 subjects per group are required to detect significant differences. Therefore, the total sample size would be made up of 368 participants, estimating losses of 5%.
For variables description and hypotheses contrast, the statistical program SPSS version 22.0 for Windows will be used, working with a significance level of 5%.
Read the detailed description
Background: ultrasound-guided puncture seems to facilitate cannulation of the radial artery in patients who undergoing cardiac catheterization. The efficacy of reactive hyperemia has also been seen, however, the combination of different methods in radial artery puncture has not been evaluated.
Aims: to evaluate the success rate of radial artery cannulation in patients undergoing cardiac catheterization, using different methods such as palpation, hyperemia or ultrasound-guided puncture, together or each method separately. Specifically, success rate at the first attempt, attempts numbers with each technique and time spent will be assessed. Possible complications and perceived pain by the participant in each technique will be evaluated.
The hypothesis is that there are different success rates for each puncture technique when cannulating radial artery for cardiac catheterization.
Methods: randomized clinical trial with four parallel groups, with operator blinding.
Participation in the clinical trial does not imply an increased risk for the patient since both ultrasound and hyperemia are harmless and non-invasive methods.
Once the participant agrees to be included in the study and signs the informed consent, they are randomized to one of four groups: ultrasound and hyperemia puncture (for hyperemia, a blood pressure cuff is inflated 50mmHg above systolic until a maximum of 200mmHg for 5 minutes before puncture, it is known that maximum hyperemia is achieved 60 to 180 seconds after deflation), ultrasound puncture only, hyperemia puncture only, palpation puncture (control group).
Similarly, before the puncture, an ultrasound assessment of the participant's radial artery (diameter, depth and systolic peak velocity) will be performed. Once in the intervention room, the puncture will be performed according to the corresponding method. The puncturing operator will not perform the randomization or the ultrasound assessment to avoid bias.
Participation in the study ends once the radial artery has been cannulated with the guide according to the Seldinger technique.
The randomization sequence was generated by the center's Biostatistics and Epidemiology Unit. The four possible puncture methods were stratified by operator.
All operators have performed hundreds of radial punctures by palpation and more than 20 ultrasound-guided punctures, as established by the study of the learning curve carried out by Jayanti S et al, before starting participants recruitment.
All the variables will be collected in an ad hoc questionnaire designed to respond all study objectives.
Regarding the sample size, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 92 subjects per group are required to detect a statistically significant difference, which for the control group (traditional puncture) is expected to be 0.44 the percentage of success at the first puncture attempt, and for the rest is at least 0.65. Therefore, the total sample size would be made up of 368 participants, estimating a follow-up loss of 5%.
Regarding the statistical analysis, the quantitative variables will be described with the mean and the standard deviation if they follow a normal distribution, or with the median and the interquartile range if they do not follow a normal distribution. The normality will be contrasted using the Kolmogorov-Smirnov test. The qualitative variables will be described through the distribution of frequencies and percentages.
For the comparisons of the quantitative variables following a normal distribution, the one factor analysis of variance (ANOVA) will be used for the global comparison, and the Student's t-test in the comparisons by pairs. For variables do not following a normal distribution, the Kruskal Wallis test will be used in the global comparison, and Dunn's test in pairwise comparisons. For comparisons of qualitative variables, the Chi-square test will be used, or Fisher's exact test in those situations in which the criteria for using the Chi-square are not met. In pairwise comparisons, the Bonferroni correction will be applied for multiple comparisons.
In all hypothesis contrasts, a significance level of 5% will be used. The statistical program SPSS version 22.0 for Windows will be used.
- Conditions
- Myocardial Ischemia, Cardiac Catheterization
- Being tested
- Methods for cannulating the radial artery in a cardiac catheterization
- Keywords
- Radial Artery, Hyperemia, Ultrasonography
- Medical subject headings
- Myocardial Ischemia, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methods for cannulating the radial artery in a cardiac catheterizationProcedure or surgery
The puncture will be performed in each participant according to the method has been assigned randomly: ultrasound and hyperemia, ultrasound only, hyperemia only, palpation.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound and hyperemia | Experimental | Use of ultrasound and hyperemia to puncture radial artery. Receives: Procedure: Methods for cannulating the radial artery in a cardiac catheterization |
| Ultrasound only | Experimental | Use of ultrasound only to puncture radial artery. Receives: Procedure: Methods for cannulating the radial artery in a cardiac catheterization |
| Hyperemia only | Experimental | Use of hyperemia and palpation to puncture radial artery. Receives: Procedure: Methods for cannulating the radial artery in a cardiac catheterization |
| Palpation | No intervention | Use of palpation to puncture radial artery (control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of success at first puncture attempt
It is assessed whether the radial artery is cannulated in the first puncture without removing the needle from the skin
Measured: During radial artery puncture, it will be assessed whether cannulation can be achieved at the first attempt
Number of punctures
The punctures number have been necessary to achieve radial artery cannulation will be measured
Measured: During radial artery cannulation, punctures number have been necessary will be measured
Time to cannulate
The time in minutes and seconds has been necessary to cannulate radial artery will be measured
Measured: During radial artery cannulation, the time will be measured from the needle is inserted into the skin for the first time until the guidewire enters the arterial lumen, stopping time when the needle is out of the skin (if more than one puncture)
Secondary outcomes (2)
Rate of possible complications
Complications that may arise after arterial puncture such as spasm, hematoma, cyanosis, coldness, paresthesia, etc.
Measured: During or just after the cardiac catheterization, the possible complications related to the arterial puncture will be assessed
Perceived pain
The perceived pain by the patient will be recorded on a 0 to 10 scale, with 0 being no pain and 10 being the maximum possible imagined pain
Measured: The perceived pain will be recorded at the end of the radial artery cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start17 Feb 2022
- Primary completion27 Dec 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan C Sánchez, RN, BsC, MSc, Principal investigator, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364463
- Sponsor's protocol ID
- EC093-21_FJD
- Acronym
- RadialHUS
- Status last verified
- Sep 2023
- First submitted
- 3 May 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completing the recruitment, the data collected will be analyzed for publication
Publications
Deftereos S, Giannopoulos G, Kossyvakis C, Driva M, Kaoukis A, Raisakis K, Theodorakis A, Panagopoulou V, Lappos S, Tampaki E, Pyrgakis V, Stefanadis C. Radial artery flow-mediated dilation predicts arterial spasm during transradial coronary interventions. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):649-54. doi: 10.1002/ccd.22688.
PubMed 20549693Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.
PubMed 21470671Doubell J, Kyriakakis C, Weich H, Herbst P, Pecoraro A, Moses J, Griffiths B, Snyman HW, Kabwe L, Du Toit R, Joubert L, Hassan K, Doubell A. Radial artery dilatation to improve access and lower complications during coronary angiography: the RADIAL trial. EuroIntervention. 2021 Mar 19;16(16):1349-1355. doi: 10.4244/EIJ-D-19-00207.
PubMed 31746742Thijssen DHJ, Bruno RM, van Mil ACCM, Holder SM, Faita F, Greyling A, Zock PL, Taddei S, Deanfield JE, Luscher T, Green DJ, Ghiadoni L. Expert consensus and evidence-based recommendations for the assessment of flow-mediated dilation in humans. Eur Heart J. 2019 Aug 7;40(30):2534-2547. doi: 10.1093/eurheartj/ehz350.
PubMed 31211361Lanza GA, Cesarano M, De Vita A, Villano A, Milo M, Russo G, Crea F. Effect of Remote Ischemic Preconditioning on Coronary Procedure-Related Impairment of Vascular Dilator Function. J Am Coll Cardiol. 2016 Dec 6;68(22):2490-2492. doi: 10.1016/j.jacc.2016.08.071. No abstract available.
PubMed 27908357Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14.
PubMed 25596790Jayanti S, Juergens C, Makris A, Hennessy A, Nguyen P. The Learning Curves for Transradial and Ultrasound-Guided Arterial Access: An Analysis of the SURF Trial. Heart Lung Circ. 2021 Sep;30(9):1329-1336. doi: 10.1016/j.hlc.2021.02.006. Epub 2021 Mar 12.
PubMed 33722490
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation in Patients Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT05364463
- Acronym / sponsor ID
- RadialHUS / EC093-21_FJD
- Conditions
- Myocardial Ischemia, Cardiac Catheterization
- Keywords
- Radial Artery, Hyperemia, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 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.
Aims: to evaluate the success rate of radial artery cannulation in patients undergoing cardiac catheterization, using different methods such as palpation, hyperemia or ultrasound-guided puncture, together or each method separately. Specifically, the success rate at the first attempt, the number of attempts with each technique and the time spent will be assessed.
The hypothesis is that there are different success rates for each puncture technique when cannulating radial artery for cardiac catheterization.
Methods: randomized clinical trial with four parallel groups, with operator blinding. Those patients who will have the radial artery cannulated for an interventional cardiology procedure will be selected.
Once the participant agrees to be included in the study and signs the informed consent, they are randomized to one of four groups: ultrasound and hyperemia puncture, only ultrasound puncture, only hyperemia puncture, palpation puncture (control group). Subsequently, an ultrasound assessment of the participant's radial artery (diameter, depth and systolic peak velocity) will be performed. Once in the intervention room, the puncture will be performed according to the corresponding method. The puncturing operator in charge will not perform the randomization or the ultrasound assessment to avoid bias.
Variables will be collected in an ad hoc questionnaire designed to respond all study aims. Regarding the sample size, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 92 subjects per group are required to detect significant differences. Therefore, the total sample size would be made up of 368 participants, estimating losses of 5%.
For variables description and hypotheses contrast, the statistical program SPSS version 22.0 for Windows will be used, working with a significance level of 5%.
Detailed description
Background: ultrasound-guided puncture seems to facilitate cannulation of the radial artery in patients who undergoing cardiac catheterization. The efficacy of reactive hyperemia has also been seen, however, the combination of different methods in radial artery puncture has not been evaluated.
Aims: to evaluate the success rate of radial artery cannulation in patients undergoing cardiac catheterization, using different methods such as palpation, hyperemia or ultrasound-guided puncture, together or each method separately. Specifically, success rate at the first attempt, attempts numbers with each technique and time spent will be assessed. Possible complications and perceived pain by the participant in each technique will be evaluated.
The hypothesis is that there are different success rates for each puncture technique when cannulating radial artery for cardiac catheterization.
Methods: randomized clinical trial with four parallel groups, with operator blinding.
Participation in the clinical trial does not imply an increased risk for the patient since both ultrasound and hyperemia are harmless and non-invasive methods.
Once the participant agrees to be included in the study and signs the informed consent, they are randomized to one of four groups: ultrasound and hyperemia puncture (for hyperemia, a blood pressure cuff is inflated 50mmHg above systolic until a maximum of 200mmHg for 5 minutes before puncture, it is known that maximum hyperemia is achieved 60 to 180 seconds after deflation), ultrasound puncture only, hyperemia puncture only, palpation puncture (control group).
Similarly, before the puncture, an ultrasound assessment of the participant's radial artery (diameter, depth and systolic peak velocity) will be performed. Once in the intervention room, the puncture will be performed according to the corresponding method. The puncturing operator will not perform the randomization or the ultrasound assessment to avoid bias.
Participation in the study ends once the radial artery has been cannulated with the guide according to the Seldinger technique.
The randomization sequence was generated by the center's Biostatistics and Epidemiology Unit. The four possible puncture methods were stratified by operator.
All operators have performed hundreds of radial punctures by palpation and more than 20 ultrasound-guided punctures, as established by the study of the learning curve carried out by Jayanti S et al, before starting participants recruitment.
All the variables will be collected in an ad hoc questionnaire designed to respond all study objectives.
Regarding the sample size, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 92 subjects per group are required to detect a statistically significant difference, which for the control group (traditional puncture) is expected to be 0.44 the percentage of success at the first puncture attempt, and for the rest is at least 0.65. Therefore, the total sample size would be made up of 368 participants, estimating a follow-up loss of 5%.
Regarding the statistical analysis, the quantitative variables will be described with the mean and the standard deviation if they follow a normal distribution, or with the median and the interquartile range if they do not follow a normal distribution. The normality will be contrasted using the Kolmogorov-Smirnov test. The qualitative variables will be described through the distribution of frequencies and percentages.
For the comparisons of the quantitative variables following a normal distribution, the one factor analysis of variance (ANOVA) will be used for the global comparison, and the Student's t-test in the comparisons by pairs. For variables do not following a normal distribution, the Kruskal Wallis test will be used in the global comparison, and Dunn's test in pairwise comparisons. For comparisons of qualitative variables, the Chi-square test will be used, or Fisher's exact test in those situations in which the criteria for using the Chi-square are not met. In pairwise comparisons, the Bonferroni correction will be applied for multiple comparisons.
In all hypothesis contrasts, a significance level of 5% will be used. The statistical program SPSS version 22.0 for Windows will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ultrasound and hyperemia | Experimental | Procedure: Methods for cannulating the radial artery in a cardiac catheterizationUse of ultrasound and hyperemia to puncture radial artery. |
| Ultrasound only | Experimental | Procedure: Methods for cannulating the radial artery in a cardiac catheterizationUse of ultrasound only to puncture radial artery. |
| Hyperemia only | Experimental | Procedure: Methods for cannulating the radial artery in a cardiac catheterizationUse of hyperemia and palpation to puncture radial artery. |
| Palpation | No intervention | –Use of palpation to puncture radial artery (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years of age
- understand, accept and sign the informed consent
- participants undergoing radial artery cannulation for a diagnostic, therapeutic, or structural interventional cardiology procedure
- patent radial artery in the previous ultrasound evaluation
Key exclusion criteria (4 listed)
- systolic blood pressure greater than 150mmHg
- diagnosis of acute myocardial infarction (with or without ST-segment elevation)
- previous surgeries that have affected the arterial system of the upper limbs (arteriovenous fistula, radial artery for bypass surgery, etc.)
- language barrier that hinders a clear study understanding for potential participant
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 |
|---|---|---|
| Methods for cannulating the radial artery in a cardiac catheterizationThe puncture will be performed in each participant according to the method has been assigned randomly: ultrasound and hyperemia, ultrasound only, hyperemia only, palpation. | Procedure or surgery | Hyperemia only, Ultrasound and hyperemia, Ultrasound only |
Primary outcome
Rate of success at first puncture attempt
Time frame: During radial artery puncture, it will be assessed whether cannulation can be achieved at the first attempt
It is assessed whether the radial artery is cannulated in the first puncture without removing the needle from the skin
Number of punctures
Time frame: During radial artery cannulation, punctures number have been necessary will be measured
The punctures number have been necessary to achieve radial artery cannulation will be measured
Time to cannulate
Time frame: During radial artery cannulation, the time will be measured from the needle is inserted into the skin for the first time until the guidewire enters the arterial lumen, stopping time when the needle is out of the skin (if more than one puncture)
The time in minutes and seconds has been necessary to cannulate radial artery will be measured
2 secondary outcomes
Rate of possible complications
Time frame: During or just after the cardiac catheterization, the possible complications related to the arterial puncture will be assessed
Perceived pain
Time frame: The perceived pain will be recorded at the end of the radial artery cannulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 20549693Deftereos S, Giannopoulos G, Kossyvakis C, Driva M, Kaoukis A, Raisakis K, Theodorakis A, Panagopoulou V, Lappos S, Tampaki E, Pyrgakis V, Stefanadis C. Radial artery flow-mediated dilation predicts arterial spasm during transradial coronary interventions. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):649-54. doi: 10.1002/ccd.22688.
- Background: PubMed 21470671Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.
- Background: PubMed 31746742Doubell J, Kyriakakis C, Weich H, Herbst P, Pecoraro A, Moses J, Griffiths B, Snyman HW, Kabwe L, Du Toit R, Joubert L, Hassan K, Doubell A. Radial artery dilatation to improve access and lower complications during coronary angiography: the RADIAL trial. EuroIntervention. 2021 Mar 19;16(16):1349-1355. doi: 10.4244/EIJ-D-19-00207.
- Background: PubMed 31211361Thijssen DHJ, Bruno RM, van Mil ACCM, Holder SM, Faita F, Greyling A, Zock PL, Taddei S, Deanfield JE, Luscher T, Green DJ, Ghiadoni L. Expert consensus and evidence-based recommendations for the assessment of flow-mediated dilation in humans. Eur Heart J. 2019 Aug 7;40(30):2534-2547. doi: 10.1093/eurheartj/ehz350.
- Background: PubMed 27908357Lanza GA, Cesarano M, De Vita A, Villano A, Milo M, Russo G, Crea F. Effect of Remote Ischemic Preconditioning on Coronary Procedure-Related Impairment of Vascular Dilator Function. J Am Coll Cardiol. 2016 Dec 6;68(22):2490-2492. doi: 10.1016/j.jacc.2016.08.071. No abstract available.
- Background: PubMed 25596790Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14.
- Background: PubMed 33722490Jayanti S, Juergens C, Makris A, Hennessy A, Nguyen P. The Learning Curves for Transradial and Ultrasound-Guided Arterial Access: An Analysis of the SURF Trial. Heart Lung Circ. 2021 Sep;30(9):1329-1336. doi: 10.1016/j.hlc.2021.02.006. Epub 2021 Mar 12.
- ESC GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No. After completing the recruitment, the data collected will be analyzed for publication
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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. This study is not recruiting at the moment.
Juan C Sánchez, RN, BsC, MSc principal investigator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methods for cannulating the radial artery in a cardiac catheterization in people with Myocardial Ischemia and Cardiac Catheterization, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. 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 Spain. 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?
Results are not available in the source record.
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?
Rate of success at first puncture attempt (time frame: During radial artery puncture, it will be assessed whether cannulation can be achieved at the first attempt). The study lists 3 primary outcomes in all. 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 NCT05364463, which also lists 7 linked publications.
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 29 Sep 2023.