NCT01853943

Brief Summary

Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers. To evaluate if transradial approach for percutaneous coronary procedures may affect muscle force of the hand, thumb and index finger the investigators use a standardized hand-grip manometer and a pinch gauge before the transradial procedure, the day after the procedures and after few months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

May 10, 2013

Last Update Submit

March 2, 2015

Conditions

Radial Artery Occlusion

Keywords

Transradial approachradial occlusionhand gripcoronary angiography

Outcome Measures

Primary Outcomes (1)

  • Hand grip strength

    The variation in had grip strength and thumb pinch after the procedure (the day after and at 30 day follow-up) compared to baseline in patients with patent radial artery compared to occluded radial artery.

    3 months

Secondary Outcomes (1)

  • Radial occlusion

    3 months

Study Arms (2)

Patent radial artery

Patient with patent radial artery after the percutaneous coronary procedure

Occluded radial artery

Patients with occluded radial artery after the procedure

Eligibility Criteria

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

Stable patients who undergo elective percutaneous transradial coronary procedures

You may qualify if:

  • Stable patients who undergo elective percutaneous transradial coronary procedures

You may not qualify if:

  • hemodynamic instability,
  • acute coronary syndromes,
  • haemodialysis patients with an arteriovenous fistula,
  • sheath diameter \> 6 French,
  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Sandro Pertini - ASL RMB

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Arterial Occlusive DiseasesBites and Stings

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Alessandro Sciahbasi, MD

    Ospedale Sandro Pertini - ASL RMB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 15, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

IT(1)