NCT03486470

Brief Summary

The purpose of this study is to determine if there is a difference in the size and the depth of the radial artery at the access points for established radial and new distal radial approach for the arteries of both arms

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Status
unknown

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

February 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

February 28, 2018

Last Update Submit

March 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of ultrasound derived diameters of radial artery measured at sites related to two different transradial arterial approaches for catheterization

    Measuring diameters of the radial artery at the access points for well established radial and new distal radial approach and finding or not a significant difference could have some implications for choosing the access radial site. At the end of a routine echocardiographic evaluation, four short axis measurements (one proximal and one distal on each arm) of the radial artery diameters will be done with a vascular probe.

    1 day

Secondary Outcomes (2)

  • Comparison of ultrasound derived depth of radial artery measured at sites related to two different transradial arterial approaches for catheterization

    1 day

  • Impact of sex, BMI, hand-dominance or comorbidities on the size and the depth of the arterial segments

    1 day

Interventions

Measuring the diameter and the depth of two radial segments on both arms

Eligibility Criteria

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

Patients admitted to the Cardilogy Department

You may qualify if:

  • Patients \>18 years old admitted to the Cardiology Department

You may not qualify if:

  • Previous transradial procedures
  • Arm AV fistula for dialysis access
  • History of upper limb peripheral arterial disease
  • Hemiparesis
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Valentin Krastev, MD

    Dr. Stephan Cherkezov Hospital

    PRINCIPAL INVESTIGATOR
  • Haralamby Benov, MD

    Dr. Stephan Cherkezov Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentin Krastev, MD

CONTACT

Haralamby Benov, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of CathLab

Study Record Dates

First Submitted

February 28, 2018

First Posted

April 3, 2018

Study Start

April 15, 2018

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

April 3, 2018

Record last verified: 2018-03