Heparin Dose for Radial Angiography

Coronary Angiograph Clinical Trial

Official title:

Low Versus High Dose Unfractionated Heparin in Patients Undergoing Angiography Via the Radial Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634438
• Other study ID #: Pro00001925
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2012
• Last updated: July 2, 2012
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: UofA ethics board
• Study type: Interventional

Clinical Trial Summary

At present, coronary angiogram is usually performed either through an artery in your groin or wrist. An important limitation of the wrist approach is an increase rate of blockage of the wrist artery. It is possible that the dose of blood thinner (i.e. heparin) may decrease the risk of blockage. Early studies seem to suggest that higher dose is required to reduce the risk of this important complication. However, to date there has not been a definitive study to determine the most appropriate heparin dose for the prevention of this complication. The main goal of this study is to determine the appropriate heparin dose to prevent wrist artery blockage and to determine risk factors for developing such a complication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years of age who were referred for either urgent or elective cardiac catheterization were eligible for the study if a normal Allen's test was demonstrated

Exclusion Criteria:

• myocardial infarction with shock,

• ST-elevation myocardial infarction,

• patients undergoing planned percutaneous coronary intervention, and

• patients in whom transradial approach is contraindicated such as hemodialysis patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Angiograph

Intervention

Drug:
• unfractionated heparin
unfractionated heparin

Locations

Country	Name	City	State
Canada	Mazankowski Alberta Heart Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radial artery occlusion	The primary endpoint was radial artery occlusion defined as absence palpable radial artery with no flow as assessed by Doppler study	one month	Yes