Condition category
Circulatory System
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
04/07/2007
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 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

http://www.umcg.nl/azg/nl/english/azg/

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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17597524

Publication citations

  1. 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.

Additional files

Editorial Notes