Contact information
Type
Scientific
Primary contact
Dr J. de Vries
ORCID ID
Contact details
Thorax Centre
University Medical Centre Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
j.de.vries@thorax.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Neurostimulation can improve collateral perfusion measured as a coronary wedge pressure (Pw)/aortic pressure (Pa) ratio, during acute coronary occlusion.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Angina pectoris, electrical neurostimulation, coronary collaterals, angioplasty
Intervention
The intervention was electrical neurostimulation, during five minutes before and during the one-minute ischaemic episode. Within a patient we measured during the one-minute ischaemic episode the collateral perfusion, with and without electrical neurostimulation. The ischaemic episode was established by balloon inflation during elective PCI.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary endpoint was collateral perfusion, the Pw/Pa ratio. This was measured during a one-minute balloon inflation during PCI. The Pw/Pa ratio was measured in each patient during two ischaemic episodes. To compare the Pw/Pa ratio with and without electrical neurostimulation, the Pw/Pa ratio is measured intracoronary, using a pressure wire.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
10/01/2006
Overall trial end date
10/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with stable angina
2. Evidence of myocardial ischaemia
3. Planned for elective Percutaneous Coronary Intervention (PCI)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Recent myocardial infarction
2. Prior coronary artery bypass grafting
3. Undtable angina
4. Conduction disturbances
5. Pacemaker
6. Internal cardio-defibrillator
Recruitment start date
10/01/2006
Recruitment end date
10/05/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Thorax Centre
Groningen
9713 GZ
Netherlands
Sponsor information
Organisation
University Medical Centre Groningen (UMCG) (The Netherlands)
Sponsor details
Thorax Centre
Department of Cardiology
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Groningen (UMCG) (The Netherlands)
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
-
Results
de Vries J, Anthonio RL, Dejongste MJ, Jessurun GA, Tan ES, de Smet BJ, van den Heuvel AF, Staal MJ, Zijlstra F, The effect of electrical neurostimulation on collateral perfusion during acute coronary occlusion., BMC Cardiovasc Disord, 2007, 7, 18, doi: 10.1186/1471-2261-7-18.