Hand Grip Test and Transradial Coronary Procedures

Radial Artery Occlusion Clinical Trial

— HANGAR  

Official title:

Hand Grip Test After Transradial Percutaneous Coronary Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853943
• Other study ID #: Pertini-02
• Status: Completed
• Phase: N/A
• First received: May 10, 2013
• Last updated: March 2, 2015
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Ospedale Sandro Pertini, Roma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Stable patients who undergo elective percutaneous transradial coronary procedures

Exclusion Criteria:

• hemodynamic instability,

• acute coronary syndromes,

• haemodialysis patients with an arteriovenous fistula,

• sheath diameter > 6 French,

• age < 18 years

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Radial Artery Occlusion

Locations

Country	Name	City	State
Italy	Ospedale Sandro Pertini - ASL RMB	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Sandro Pertini, Roma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Radial occlusion	The rate of radial occlusion after transradial coronary procedures	3 months	Yes