NCT01634438

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

2.4 years

First QC Date

June 28, 2012

Last Update Submit

July 2, 2012

Conditions

Coronary Angiograph

Keywords

coronary angiography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

low dose heparin

EXPERIMENTAL

30 units per kilogram of unfractionated heparin

Drug: unfractionated heparin

High dose heparin

ACTIVE COMPARATOR

70 units per kilogram of unfractionated heparin (UFH) intravenously

Drug: unfractionated heparin

Interventions

unfractionated heparinDRUG

unfractionated heparin

High dose heparinlow dose heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 6, 2012

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

CA(1)