Coronary AngiographPhase 4NCT01634438
Heparin Dose for Radial Angiography
A Phase 4 study testing unfractionated heparin in people with Coronary Angiograph, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiograph
- What is being tested?
- unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Versus High Dose Unfractionated Heparin in Patients Undergoing Angiography Via the Radial Artery
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.
- Conditions
- Coronary Angiograph
- Being tested
- unfractionated heparin
- Keywords
- coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unfractionated heparinDrug
unfractionated heparin
| Study group | Role | What they receive |
|---|---|---|
| low dose heparin | Experimental | 30 units per kilogram of unfractionated heparin Receives: Drug: unfractionated heparin |
| High dose heparin | Active comparator | 70 units per kilogram of unfractionated heparin (UFH) intravenously Receives: Drug: unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
radial artery occlusion
The primary endpoint was radial artery occlusion defined as absence palpable radial artery with no flow as assessed by Doppler study
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Welsh, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634438
- Sponsor's protocol ID
- Pro00001925
- Status last verified
- Jul 2012
- First submitted
- 28 Jun 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Versus High Dose Unfractionated Heparin in Patients Undergoing Angiography Via the Radial Artery
- ClinicalTrials.gov ID
- NCT01634438
- Acronym / sponsor ID
- Pro00001925
- Conditions
- Coronary Angiograph
- Keywords
- coronary angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose heparin | Experimental | Drug: unfractionated heparin30 units per kilogram of unfractionated heparin |
| High dose heparin | Active comparator | Drug: unfractionated heparin70 units per kilogram of unfractionated heparin (UFH) intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unfractionated heparinunfractionated heparin | Drug | High dose heparin, low dose heparin |
Primary outcome
radial artery occlusion
Time frame: one month
The primary endpoint was radial artery occlusion defined as absence palpable radial artery with no flow as assessed by Doppler study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing unfractionated heparin in people with Coronary Angiograph, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radial artery occlusion (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2012.