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Het effect van helium op de doorbloeding van het hart.


- candidate number8441
- NTR NumberNTR2504
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-sep-2010
- Secondary IDs09/328 METC AMC
- Public TitleHet effect van helium op de doorbloeding van het hart.
- Scientific TitleThe effect of helium inhalation on coronary circulation and vessel diameter.
- ACRONYMHelium and the coronary circulation
- hypothesisHelium inhalation influences the coronary circulation and/or vessel diameter.
- Healt Condition(s) or Problem(s) studiedHelium, Coronary circulation, Coronary vessel diameter, Coronary micro vascular resistance
- Inclusion criteria1. Elective Percutaneous coronary intervention (PCI) of the left anterior descending artery (LAD);
2. Age >18 years;
3. Written informed consent.
- Exclusion criteria1. Acute coronary syndrome;
2. Cardiogenic shock;
3. Prior coronary artery bypass grafting (CABG);
4. Presence of a significant left main coronary artery stenosis (> 50% diameter stenosis);
5. Diffuse disease;
6. Diabetes;
7. Severe pulmonary disease;
8. Kidney failure (clearance <30 ml/min);
9. Liver failure;
10. Prior revascularisation;
11. Consecutive stenoses in a single artery;
12. Expected inability to complete the study protocol;
13. Participation in another study using ionizing radiation within the last year;
14. Employed in a profession using ionizing radiation;
15. Use of a non-selective betablokker.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-sep-2010
- planned closingdate31-dec-2011
- Target number of participants20
- InterventionsDuring PCI, participants will breathe helium 79% during 10 minutes. Measurements will be done both before and after helium inhalation.
- Primary outcomeCoronary flow reserve (CFR) in the LAD.
- Secondary outcome1. Fractional flow reserve (FFR) in the LAD;
2. MR in the LAD;
3. Lumen diameter of the RCx;
4. Vessel diameter of the RCx;
5. CFR in the RCx;
6. FFR in the RCx;
7. MR in the RCx;
8. Collateral flow index (CFI);
9. Global hemodynamic parameters during helium application;
10. Complications during and following PCI.
- TimepointsBefore and after helium inhalation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. Daniel Brevoord
- CONTACT for SCIENTIFIC QUERIESMD, MA, DEAA B. Preckel
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIn animal models of myocardial infarction, helium pre- and postconditioning has shown promising results in the reduction of infarct size. Since helium , which is a registered medical gas, has no cardiovascular side-effects known until now, it could provide an attractive therapeutic agent to reduce ischemia reperfusion injury in clinical settings of ischemia-reperfusion, e.g. acute myocardial infarction. It appears that helium has no effects on hemodynamics. However, whether helium has any effect on the coronary circulation is not known. This study investigates whether helium influences coronary flow, coronary pressure, microvascular resistance and vessel diameter of coronary arteries in humans. The study is an open-label single center study with a cross-over design, in which 20 patients scheduled for elective PCI of the LAD will be included. In all the participants measurements will be done before and after helium inhalation (79% helium with 21% oxygen).
- Main changes (audit trail)
- RECORD13-sep-2010 - 23-sep-2010


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