The number of cerebral emboli during coronary angiography depends on the access site
| ISRCTN | ISRCTN60243835 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60243835 | 
| Secondary identifying numbers | A1 | 
- Submission date
- 09/11/2009
- Registration date
- 10/12/2009
- Last edited
- 10/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
        
            
            Record updated in last year
        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr Jesper Nyman
Scientific
                                        Scientific
                                                Department of Cardiothoracic Surgery and Anaesthesiology
Karolinska University Hospital
Stockholm
17176
Sweden
                                                
Study information
| Study design | Randomised single-centre clinical trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Hospital | 
| Study type | Screening | 
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet | 
| Scientific title | The number of cerebral emboli during coronary angiography depends on the access site: a randomised single-centre clinical trial | 
| Study objectives | There are more cerebral emboli during coronary angiography when accessing radial artery compared to femoral artery. | 
| Ethics approval(s) | The Local Board of Ethics (EPN) in Sweden approved on the 4th October 2006 (ref: 2006/1077-31/2) | 
| Health condition(s) or problem(s) studied | 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 | 
| Primary outcome measure | 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 study start date | 01/02/2007 | 
| Completion date | 01/01/2009 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Adult | 
| Sex | All | 
| Target number of participants | 50 | 
| Key inclusion criteria | 1. Outpatients with stable angina pectoris planned for coronary angiography 2. Male and female 3. Aged 40 - 79 years | 
| Key exclusion criteria | 1. Positive Allens test 2. No written informed consent | 
| Date of first enrolment | 01/02/2007 | 
| Date of final enrolment | 01/01/2009 | 
Locations
Countries of recruitment
- Sweden
Study participating centre
                                            Department of Cardiothoracic Surgery and Anaesthesiology
                                        
                                        
                                            
                                            Stockholm
17176
Sweden
                                    17176
Sweden
Sponsor information
                                            Karolinska University Hospital (Sweden) 
Hospital/treatment centre
                                        Hospital/treatment centre
                                                c/o Jan van der Linden
Department of Cardiothoracic Surgery and Anaesthesiology
Stockholm
17176
Sweden
                                                
| Website | http://www.ki.se/ | 
|---|---|
| https://ror.org/00m8d6786 | 
Funders
Funder type
Hospital/treatment centre
                                                Karolinska University Hospital (Sweden)
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | Not provided at time of registration | 
| IPD sharing plan | 

