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WithdrawnNCT02017028Updated Dec 5, 2023

Correlation Between Endothelial Function and Trans Radial-procedural Events

An observational study in Injury; Blood Vessel, Wrist, Radial Artery, sponsored by Sheba Medical Center. Withdrawn at 1 site in Israel. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Sheba Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 90 Years
Sex
All
01

Study 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 the detailed description

All patient will undergo pre procedural endoPAT assessment for endothelial dysfunction

02

Conditions studied

  • Injury; Blood Vessel, Wrist, Radial Artery

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03

In context

Wounds and Injuries

5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.

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Lead sponsor

Sheba Medical Center is the lead sponsor of 677 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients planned for elective trans-radial cath

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients without angiographic proof of coronary disease, with scheduled elective coronary angiographic evaluation by radial approach.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. To assess relation between the presence of previous endothelial dysfunction and radial artery vasospasm

    Time frame: 1 month

07

Study locations

1 site
  • Sheba Medical center
    Ramat Gan, Israel
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2013
First posted
Dec 20, 2013
Start
Jan 2015
Primary completionActual
Dec 30, 2016
CompletionActual
Dec 30, 2016
Last update
Dec 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02017028
Responsible party
Sponsor
First posted
Dec 20, 2013
Start date
Jan 2015
Primary completion
Dec 30, 2016
Completion
Dec 30, 2016
Last update
Dec 5, 2023

Study contacts

Amit Segev, MD
principal investigator · Sheba MC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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