The effect of electrical neurostimulation on collateral perfusion during acute coronary occlusion
| ISRCTN | ISRCTN81465865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81465865 |
| Protocol serial number | N/A |
| Sponsor | University Medical Centre Groningen (UMCG) (The Netherlands) |
| Funder | University Medical Centre Groningen (UMCG) (The Netherlands) |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 04/07/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. de Vries
Scientific
Scientific
Thorax Centre
University Medical Centre Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| j.de.vries@thorax.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Neurostimulation can improve collateral perfusion measured as a coronary wedge pressure (Pw)/aortic pressure (Pa) ratio, during acute coronary occlusion. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 10/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Patients with stable angina 2. Evidence of myocardial ischaemia 3. Planned for elective Percutaneous Coronary Intervention (PCI) |
| Key exclusion criteria | 1. Recent myocardial infarction 2. Prior coronary artery bypass grafting 3. Undtable angina 4. Conduction disturbances 5. Pacemaker 6. Internal cardio-defibrillator |
| Date of first enrolment | 10/01/2006 |
| Date of final enrolment | 10/05/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Thorax Centre
Groningen
9713 GZ
Netherlands
9713 GZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results: | 27/06/2007 | Yes | No |
