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Hand Grip Test and Transradial Coronary Procedures (HANGAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853943
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma

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.


Condition or disease
Radial Artery Occlusion

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Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hand Grip Test After Transradial Percutaneous Coronary Procedures
Study Start Date : July 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Group/Cohort
Patent radial artery
Patient with patent radial artery after the percutaneous coronary procedure
Occluded radial artery
Patients with occluded radial artery after the procedure



Primary Outcome Measures :
  1. Hand grip strength [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Radial occlusion [ Time Frame: 3 months ]
    The rate of radial occlusion after transradial coronary procedures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable patients who undergo elective percutaneous transradial coronary procedures
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853943


Locations
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Italy
Ospedale Sandro Pertini - ASL RMB
Rome, Italy, 00168
Sponsors and Collaborators
Ospedale Sandro Pertini, Roma
Investigators
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Principal Investigator: Alessandro Sciahbasi, MD Ospedale Sandro Pertini - ASL RMB
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Responsible Party: Alessandro Sciahbasi, MD, MD, Ospedale Sandro Pertini, Roma
ClinicalTrials.gov Identifier: NCT01853943    
Other Study ID Numbers: Pertini-02
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015
Keywords provided by Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma:
Transradial approach
radial occlusion
hand grip
coronary angiography