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The effect of electrical neurostimulation on collateral perfusion during acute coronary occlusion.


- candidate number2555
- NTR NumberNTR958
- ISRCTNISRCTN81465865
- Date ISRCTN created30-mei-2007
- date ISRCTN requested22-mei-2007
- Date Registered NTR18-apr-2007
- Secondary IDs 
- Public TitleThe effect of electrical neurostimulation on collateral perfusion during acute coronary occlusion.
- Scientific TitleThe effect of electrical neurostimulation on collateral perfusion during acute coronary occlusion.
- ACRONYMN/A
- hypothesisNeurostimulation can improve collateral perfusion measured as a Pw/Pa ratio, during acute coronary occlusione.
- Healt Condition(s) or Problem(s) studiedAngina Pectoris, Angioplasty , Electrical neurostimulation , Coronary collaterals
- Inclusion criteria1. Patients with stable angina;
2. Evidence of myocardial ischemia;
3. Planned for elective percutaneous coronary intervention.
- Exclusion criteria1. Recent myocardial infarction;
2. Prior coronary artery bypass grafting;
3. Undtable angina;
4. Conduction disturbances;
5. Pacemaker;
6. Internal cardio defibrillator.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2006
- planned closingdate10-mei-2006
- Target number of participants60
- InterventionsThe intervention was electrical neurostimulation, during 5 minutes before and during the 1-minute ischemic episode. Within a patient we measured during the 1-minute ischemic episode the collateral perfusion, with and without electrical neurostimulation. The ischemic episode was established by balloon inflation during elective PCI.
- Primary outcomeThe primary endpoint was collateral perfusion, the Pw/Pa ratio. This was measured during a 1-minute balloon inflation during PCI. The Pw/Pa ratio was measured in each patient during two ischemic episodes. To compare the Pw/Pa ratio with and without electrical neurostimulation. The Pw/Pa ratio is measured intracoronary, using a pressure wire.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES J. Vries, de
- CONTACT for SCIENTIFIC QUERIES J. Vries, de
- Sponsor/Initiator University Medical Center Groningen, Thoraxcenter, Dept Cardiology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG) Thoraxcenter, Dept Cardiology
- PublicationsBMC Cardiovasc Disord. 2007 Jun 27;7:18.
- Brief summaryElectrical neurostimulation can be used to treat patients with refractory angina, it reduces angina and ischemia. Previous data have suggested that electrical neurostimulation may alleviate myocardial ischaemia through increased collateral perfusion. We investigated the effect of electrical neurostimulation on functional collateral perfusion, assessed by distal coronary pressure measurement during acute coronary occlusion. We sought to study the effect of electrical neurostimulation on collateral perfusion in a cross-over design.


Methods:
Sixty patients with stable angina and significant coronary artery disease planned for elective percutaneous coronary intervention were split in two groups. In all patients two balloon inflations of 60 seconds were performed, the first for balloon pre-dilatation of the lesion (first episode), the second for stent delivery (second episode). The Pw/Pa ratio (wedge pressure / aortic pressure) was measured during both ischaemic episodes. Group 1 received active neurostimulation during the first episode, group 2 received active neurostimulation during the second episode.
- Main changes (audit trail)
- RECORD18-apr-2007 - 18-nov-2008


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