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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01032551 |
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Date of registration:
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09/12/2009 |
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Primary sponsor: |
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Public title:
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Vascular Access Decision Aid
VADAS |
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Scientific title:
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Vascular Access Options in Coronary Angiogram Procedures: A Patient Decision Aid Randomized Controlled Trial |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01032551 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jon-David R Schwalm, BSc, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hamilton Health Sciences Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age > 18 years old
- English speaking
- able to provide informed consent
- is able to read the English language (however, if a patient is not able to read due
to visual impairment, they may still be considered for enrollment if a family member
is present to read and relay the content of the PtDA)
- candidates for both femoral and radial access as defined by the pre-assessment
checklist and subsequently approved by their treating physician
Exclusion Criteria:
- any patients not meeting the inclusion criteria
- the interventional cardiologist performing the procedure does not feel comfortable or
believes the patient is ineligible for either access (may include reason's not
specifically outlined in the pre-assessment checklist)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atherosclerosis
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Coronary Artery Disease
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Intervention(s)
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Behavioral: Vascular Access Decision Aid
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Primary Outcome(s)
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The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions.
[Time Frame: 1 Day]
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Secondary Outcome(s)
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Access site Complications (Significant bleeding, hematoma, pseudoaneurysm, or vascular compromise requiring intervention)
[Time Frame: 1 day]
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Angiographic Success (PCI) as determined by interventionalist performing the procedure.
[Time Frame: 1 day]
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Improved knowledge and accurate risk perception of the patient's health care option assessed by a pre-discharge questionnaire.
[Time Frame: 1 Day]
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Improved value congruence with the patient's chosen option as assessed by a pre-discharge questionnaire.
[Time Frame: 1 Day]
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Procedural time (minutes)
[Time Frame: 1 day]
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Vascular access success-ability to successfully gain vascular access through the selected site (radial versus femoral).
[Time Frame: 1 Day]
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Secondary ID(s)
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MU-09-340
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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