Condition category
Circulatory System
Date applied
09/11/2009
Date assigned
10/12/2009
Last edited
10/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jesper Nyman

ORCID ID

Contact details

Department of Cardiothoracic Surgery and Anaesthesiology
Karolinska University Hospital
Stockholm
17176
Sweden

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

http://www.ki.se/

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

Publication citations

Additional files

Editorial Notes