Injury; Blood Vessel, Wrist, Radial ArteryNCT02017028
Correlation Between Endothelial Function and Trans Radial-procedural Events
An observational study of Injury; Blood Vessel, Wrist, Radial Artery, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to investigate the relation between the previous presence of endothelial dysfunction and the development of radial artery vasospasm during the trans-radial coronary evaluation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Injury; Blood Vessel, Wrist, Radial Artery
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to 30 Dec 2016
- How long will I take part?
- 1 Day
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned for elective trans-radial cath
Who may be able to join
- Patients without angiographic proof of coronary disease, with scheduled elective coronary angiographic evaluation by radial approach.
Who cannot join
- Impossibility to perform radial approach; abnormal Barbeau test result (type C and D); previous important trauma of the upper limbs; presence of fistule for renal dialysis; lymphedema; acute myocardial infarction, severe valvular heart disease; patients with NYHA class III and IV heart failure; malignancy; active myocarditis; HIV infection or immunodeficiency state; chronic viral infection; acute systemic infection requiring antibiotics; systemic inflammatory disease; Raynaud's syndrome; refusal to sign the informed consent form. All participants must give a written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the relation between the previous presence of endothelial dysfunction and the development of radial artery vasospasm during the trans-radial coronary evaluation.
Read the detailed description
All patient will undergo pre procedural endoPAT assessment for endothelial dysfunction
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess relation between the presence of previous endothelial dysfunction and radial artery vasospasm
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2015
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury; Blood Vessel, Wrist, Radial ArteryStudies 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
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amit Segev, MD, Principal investigator, Sheba MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017028
- Sponsor's protocol ID
- SHEBA-13-0824-IB-CTIL
- Status last verified
- May 2016
- First submitted
- 10 Dec 2013
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Endothelial Function and Trans Radial-procedural Events
- ClinicalTrials.gov ID
- NCT02017028
- Acronym / sponsor ID
- SHEBA-13-0824-IB-CTIL
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2015
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 20 Dec 2013 (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.
The aim of this study is to investigate the relation between the previous presence of endothelial dysfunction and the development of radial artery vasospasm during the trans-radial coronary evaluation.
Detailed description
All patient will undergo pre procedural endoPAT assessment for endothelial dysfunction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for elective trans-radial cath
Key inclusion criteria (1 listed)
- Patients without angiographic proof of coronary disease, with scheduled elective coronary angiographic evaluation by radial approach.
Key exclusion criteria (1 listed)
- Impossibility to perform radial approach; abnormal Barbeau test result (type C and D); previous important trauma of the upper limbs; presence of fistule for renal dialysis; lymphedema; acute myocardial infarction, severe valvular heart disease; patients with NYHA class III and IV heart failure; malignancy; active myocarditis; HIV infection or immunodeficiency state; chronic viral infection; acute systemic infection requiring antibiotics; systemic inflammatory disease; Raynaud's syndrome; refusal to sign the informed consent form. All participants must give a written informed consent
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
To assess relation between the presence of previous endothelial dysfunction and radial artery vasospasm
Time frame: 1 month
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 5 Dec 2023.
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.
Amit Segev, MD principal investigator
Sheba MC
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 Injury; Blood Vessel, Wrist, Radial Artery, run by Sheba Medical Center at 1 site in Israel.
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 1 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 5 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 Israel. 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?
To assess relation between the presence of previous endothelial dysfunction and radial artery vasospasm (time frame: 1 month). 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 5 Dec 2023.