NCT02577796

Brief 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. 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.

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 Dec 2014

Shorter than P25 for all trials

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withdrawn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

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2015

Completed
Last Updated

December 4, 2023

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

October 14, 2015

Last Update Submit

November 28, 2023

Conditions

Keywords

radial artery spasmradial artery occlusionradial access

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days post procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

  • 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.

    PMID: 15899196BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Sergey Ayzenberg, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Administration Director

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 16, 2015

Study Start

December 1, 2014

Primary Completion

October 28, 2015

Study Completion

October 28, 2015

Last Updated

December 4, 2023

Record last verified: 2018-08

Locations