Arterial OcclusionNCT02577796
Radial Artery Spasm Leading to Occlusion in Patients Undergoing Coronary Angiogram Via Radial Access
An observational study of Arterial Occlusion and Arterial Spasm, run by Antonios Likourezos at 1 site in United States.
Trial summary
Radial artery access is increasingly becoming popular among interventional cardiologists for patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography secondary to its low complications rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusion, Arterial Spasm
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to 28 Oct 2015
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: All patients with an informed consent undergoing successful and atraumatic transradial cannulation for either diagnostic angiography/percutaneous coronary intervention ( PCI) over 18 years of age
Who may be able to join
- All patients with an informed consent undergoing successful and atraumatic transradial cannulation for either diagnostic angiography/percutaneous coronary intervention ( PCI) over 18 years of age
Who cannot join
- Unsuccessful and traumatic radial cannulation
- Previous failed attempts at transradial access
- Cardiogenic shock
- Negative Allen's test
- Arterio-Venous Fistula or Graft
- Prior upper extremity vascular manipulation resulting in anatomical changes
- Upper Extremity vessel stenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Radial Artery Spasm With Development of Radial Arterial Occlusion in Patients Undergoing Diagnostic Angiogram and/or Percutaneous Coronary Intervention (PCI) Via Radial Access
Radial artery access is increasingly becoming popular among interventional cardiologists for patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography secondary to its low complications rates. However, it is frequently associated with the spasm of the radial artery which can lead to difficulty in catheter manipulation during the procedure and potentially leading to vessel trauma. This vessel trauma can cause activation of coagulation system and formation of clot and subsequently the occlusion of radial artery. In this study the investigators intend to find the association of radial artery spasm with the future development of radial artery occlusion in patients who undergo PCI via radial access.
Read the detailed description
Transradial (TR) approach for PCI has gained widespread popularity secondary to decreased bleeding and reduced vascular access site complications as compared to transfemoral (TF) access. Other advantages of the TR technique include improved patient satisfaction, decreased length of stay and an enhanced economic outlook . Radial artery spasm (RAS) is a well-known obstacle associated with transradial approach and is also the most common cause of procedural failure . The reported incidence of RAS varies from 5% - 30%. Predictors of spasm include younger age, female gender, diabetes, smaller wrist circumference and lower body weight. With the advent of newer techniques such as smaller sheath size, hydrophilic coating of the sheath and use of vasodilator drugs during the procedure the incidence of RAS has reduced significantly but it still continues to be a cumbersome problem. The marked muscle mass in the radial artery wall, which is greater than that of the other arteries, and its high density in alpha-adrenergic receptors explain its propensity to go in to spasm. This spasm produces pain and difficulty in catheter manipulation and thereby increasing the chances of complications such as arterial avulsion. It's hypothesized that there might be vascular endothelial damage during catheter manipulation when patients have RAS which can activate the coagulation cascade and can result in radial artery occlusion.
Radial artery occlusion (RAO) is a frequent complication of radial artery cannulation. In the perioperative period, rates of RAO have been reported to be as high as 30%-40% . Postoperatively, however rate of RAO drop down to as low as 3%-10%. Spontaneous recanalization of the radial artery occurs frequently, and consequently, the prevalence of persistent RAO is much lower post-operatively. Radial artery occlusion can be documented by an abnormal Barbeau's test , visible obstruction on two-dimensional ultrasound or absence of Doppler flow signal distal to the puncture site. Radial artery occlusion is usually clinically quiescent and doesn't require any intervention secondary to dual blood supply of the arm. The presence of RAO, however, makes repeat ipsilateral radial access difficult. Predictors of RAO include low body weight, advanced age, female gender, degree of systemic anticoagulation, the hemostasis process as well as a low radial artery diameter to sheath size ratio. The mechanism for development of RAO are supposed to be thrombus formation following vessel injury, intimal hyperplasia and negative remodeling of the vessel after the stretching that radial artery undergoes during cannulation. Development of RAO has been related to the severity of the lesion suffered by the artery during the procedure thus, radial spasm which supposedly occurs secondary to vessel trauma may be associated with subsequent occlusion of radial artery.
There has been only one study to date by Ruiz-Salmerón et al that looked at the association of RAS with the development of RAO. They found no significant difference in the radial artery occlusion rate in patients who experienced radial artery spasm. The major limitation of that study however was the assessment of radial artery patency by plethysmography and pulse oximetry which could underestimate the true incidence of RAO. However, in this study the investigators intend to use the Doppler ultrasound (the gold standard) to detect the patency of radial artery and will be able estimate the true incidence of RAO in patient who experience RAS during the procedure.
- Conditions
- Arterial Occlusion, Arterial Spasm
- Keywords
- radial artery spasm, radial artery occlusion, radial access
- Medical subject headings
- Arterial Occlusive Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of radial artery occlusion in patients who had spasm during coronary angiogram
Assessed by questionnaire filled out separately by the interventionist and the patient
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start1 Dec 2014
- Primary completion28 Oct 2015
- Study completion28 Oct 2015
Why it stopped: Lack of time and personnel needed to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial OcclusionStudies 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
- 0 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Sergey Ayzenberg, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577796
- Sponsor's protocol ID
- 2014-09-19
- Status last verified
- Aug 2018
- First submitted
- 14 Oct 2015
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruiz-Salmeron RJ, Mora R, Velez-Gimon M, Ortiz J, Fernandez C, Vidal B, Masotti M, Betriu A. [Radial artery spasm in transradial cardiac catheterization. Assessment of factors related to its occurrence, and of its consequences during follow-up]. Rev Esp Cardiol. 2005 May;58(5):504-11. Spanish.
PubMed 15899196
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Radial Artery Spasm With Development of Radial Arterial Occlusion in Patients Undergoing Diagnostic Angiogram and/or Percutaneous Coronary Intervention (PCI) Via Radial Access
- ClinicalTrials.gov ID
- NCT02577796
- Acronym / sponsor ID
- 2014-09-19
- Conditions
- Arterial Occlusion, Arterial Spasm
- Keywords
- radial artery spasm, radial artery occlusion, radial access
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of time and personnel needed to complete study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 28 Oct 2015 (actual)
- Study completion
- 28 Oct 2015 (actual)
- First posted
- 16 Oct 2015 (estimated)
- 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.
Radial artery access is increasingly becoming popular among interventional cardiologists for patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography secondary to its low complications rates. However, it is frequently associated with the spasm of the radial artery which can lead to difficulty in catheter manipulation during the procedure and potentially leading to vessel trauma. This vessel trauma can cause activation of coagulation system and formation of clot and subsequently the occlusion of radial artery. In this study the investigators intend to find the association of radial artery spasm with the future development of radial artery occlusion in patients who undergo PCI via radial access.
Detailed description
Transradial (TR) approach for PCI has gained widespread popularity secondary to decreased bleeding and reduced vascular access site complications as compared to transfemoral (TF) access. Other advantages of the TR technique include improved patient satisfaction, decreased length of stay and an enhanced economic outlook . Radial artery spasm (RAS) is a well-known obstacle associated with transradial approach and is also the most common cause of procedural failure . The reported incidence of RAS varies from 5% - 30%. Predictors of spasm include younger age, female gender, diabetes, smaller wrist circumference and lower body weight. With the advent of newer techniques such as smaller sheath size, hydrophilic coating of the sheath and use of vasodilator drugs during the procedure the incidence of RAS has reduced significantly but it still continues to be a cumbersome problem. The marked muscle mass in the radial artery wall, which is greater than that of the other arteries, and its high density in alpha-adrenergic receptors explain its propensity to go in to spasm. This spasm produces pain and difficulty in catheter manipulation and thereby increasing the chances of complications such as arterial avulsion. It's hypothesized that there might be vascular endothelial damage during catheter manipulation when patients have RAS which can activate the coagulation cascade and can result in radial artery occlusion.
Radial artery occlusion (RAO) is a frequent complication of radial artery cannulation. In the perioperative period, rates of RAO have been reported to be as high as 30%-40% . Postoperatively, however rate of RAO drop down to as low as 3%-10%. Spontaneous recanalization of the radial artery occurs frequently, and consequently, the prevalence of persistent RAO is much lower post-operatively. Radial artery occlusion can be documented by an abnormal Barbeau's test , visible obstruction on two-dimensional ultrasound or absence of Doppler flow signal distal to the puncture site. Radial artery occlusion is usually clinically quiescent and doesn't require any intervention secondary to dual blood supply of the arm. The presence of RAO, however, makes repeat ipsilateral radial access difficult. Predictors of RAO include low body weight, advanced age, female gender, degree of systemic anticoagulation, the hemostasis process as well as a low radial artery diameter to sheath size ratio. The mechanism for development of RAO are supposed to be thrombus formation following vessel injury, intimal hyperplasia and negative remodeling of the vessel after the stretching that radial artery undergoes during cannulation. Development of RAO has been related to the severity of the lesion suffered by the artery during the procedure thus, radial spasm which supposedly occurs secondary to vessel trauma may be associated with subsequent occlusion of radial artery.
There has been only one study to date by Ruiz-Salmerón et al that looked at the association of RAS with the development of RAO. They found no significant difference in the radial artery occlusion rate in patients who experienced radial artery spasm. The major limitation of that study however was the assessment of radial artery patency by plethysmography and pulse oximetry which could underestimate the true incidence of RAO. However, in this study the investigators intend to use the Doppler ultrasound (the gold standard) to detect the patency of radial artery and will be able estimate the true incidence of RAO in patient who experience RAS during the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with an informed consent undergoing successful and atraumatic transradial cannulation for either diagnostic angiography/percutaneous coronary intervention ( PCI) over 18 years of age
Key inclusion criteria (1 listed)
- All patients with an informed consent undergoing successful and atraumatic transradial cannulation for either diagnostic angiography/percutaneous coronary intervention ( PCI) over 18 years of age
Key exclusion criteria (7 listed)
- Unsuccessful and traumatic radial cannulation
- Previous failed attempts at transradial access
- Cardiogenic shock
- Negative Allen's test
- Arterio-Venous Fistula or Graft
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
Development of radial artery occlusion in patients who had spasm during coronary angiogram
Time frame: 30 days post procedure
Assessed by questionnaire filled out separately by the interventionist and the patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 15899196Ruiz-Salmeron RJ, Mora R, Velez-Gimon M, Ortiz J, Fernandez C, Vidal B, Masotti M, Betriu A. [Radial artery spasm in transradial cardiac catheterization. Assessment of factors related to its occurrence, and of its consequences during follow-up]. Rev Esp Cardiol. 2005 May;58(5):504-11. Spanish.
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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.
Sergey Ayzenberg, MD principal investigator
Maimonides Medical Center
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 Arterial Occlusion and Arterial Spasm, run by Antonios Likourezos at 1 site in United States.
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 7 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: withdrawn, as of the sponsor's last update on 4 Dec 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Development of radial artery occlusion in patients who had spasm during coronary angiogram (time frame: 30 days post procedure). 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 NCT02577796, 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 4 Dec 2023.