Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A1
Study information
Scientific title
The number of cerebral emboli during coronary angiography depends on the access site: a randomised single-centre clinical trial
Acronym
Study hypothesis
There are more cerebral emboli during coronary angiography when accessing radial artery compared to femoral artery.
Ethics approval
The Local Board of Ethics (EPN) in Sweden approved on the 4th October 2006 (ref: 2006/1077-31/2)
Study design
Randomised single-centre clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ischaemic heart disease
Intervention
Transcranial doppler measuring number of emboli during coronary angiography. Randomised access site during coronary angiography: radial or femoral.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Total number of cerebral emboli, measured throughout the angiography
Secondary outcome measures
Measured throughout the angiography:
1. Number of particulate cerebral emboli
2. Number of gaseous cerebral emboli
Overall trial start date
01/02/2007
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Outpatients with stable angina pectoris planned for coronary angiography
2. Male and female
3. Aged 40 - 79 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Positive Allens test
2. No written informed consent
Recruitment start date
01/02/2007
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Cardiothoracic Surgery and Anaesthesiology
Stockholm
17176
Sweden
Sponsor information
Organisation
Karolinska University Hospital (Sweden)
Sponsor details
c/o Jan van der Linden
Department of Cardiothoracic Surgery and Anaesthesiology
Stockholm
17176
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Karolinska University Hospital (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary