Hand Grip Test and Transradial Coronary Procedures | NCT01853943

Studies
Hand Grip Test and Transradial Coronary Procedures

NCT01853943

Sponsor

Ospedale Sandro Pertini, Roma

Status

Completed

Last Update Posted

Mar 3, 2015Estimated

Enrollment

107Actual

Phase

Not provided

Conditions

Radial Artery Occlusion

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

May 10, 2013

First Submission Date that Met QC Criteria

May 14, 2013

First Posted Date

May 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2015

Last Update Posted Date

Mar 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patent radial artery		Patient with patent radial artery after the percutaneous coronary procedure
Occluded radial artery		Patients with occluded radial artery after the procedure

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Radial occlusion	The rate of radial occlusion after transradial coronary procedures	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stable patients who undergo elective percutaneous transradial coronary procedures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alessandro Sciahbasi, MD	Ospedale Sandro Pertini - ASL RMB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Sandro Pertini - ASL RMB		Rome		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001157	Arterial Occlusive Diseases
D001733	Bites and Stings

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011041	Poisoning
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided