NCT02017028

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

December 5, 2023

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

December 10, 2013

Last Update Submit

December 3, 2023

Conditions

Injury; Blood Vessel, Wrist, Radial Artery

Outcome Measures

Primary Outcomes (1)

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

    1 month

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients planned for elective trans-radial cath

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Amit Segev, MD

    Sheba MC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 20, 2013

Study Start

January 1, 2015

Primary Completion

December 30, 2016

Study Completion

December 30, 2016

Last Updated

December 5, 2023

Record last verified: 2016-05

Locations

IL(1)