The primary objective is to investigate whether helium influences coronary artery circulation in humans undergoing elective percutaneous coronary interventions (PCI).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Coronary flow reserve (CFR) in the LAD
Secondary outcome
- Fractional flow reserve (FFR) in the LAD
- MR in the LAD
- Lumen diameter of the RCx
- Vessel diameter of the RCx
- CFR in the RCx
- FFR in the RCx
- MR in the RCx
- Collateral flow index (CFI)
- Global hemodynamic parameters during helium application
- Complications during and following PCI
Background summary
In animal models of myocardial infarction, helium pre- and postconditioning has
been 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 on coronary flow,
coronary pressure, microvascular resistance (MR) and vessel diameter of
coronary arteries in humans.
Study objective
The primary objective is to investigate whether helium influences coronary
artery circulation in humans undergoing elective percutaneous coronary
interventions (PCI).
Study design
Open-label intervention study.
Intervention
During the PCI procedure, participants will be breathing heliox21 (21 % oxygen
+ 79% helium) for periods of 10 minutes.
Study burden and risks
Helium is used for mechanical ventilation of patients with pulmonary disease,
e.g. asthma and chronic obstructive pulmonary diseases (COPD); thus far, no
hemodynamic side-effects are described. The measurements carried out are
considered part of normal patient care. Benefits for the study participants are
not expected. However, if helium does provide cardioprotection this could be a
safe way to improve the outcome of patients suffering from acute myocardial
infarction. Before subjecting patients with acute myocardial infarction to
helium inhalation we intend to investigate whether helium has any effects on
coronary artery hemodynamics in humans.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Elective PCI of the LAD
Age 18-80 years
Written informed consent
Exclusion criteria
- Acute coronary syndrome
- Cardiogenic shock
- Prior coronary artery bypass grafting (CABG)
- Presence of a significant left main coronary artery stenosis (> 50% diameter stenosis)
- Diffuse disease
- Diabetes
- Severe pulmonary disease
- Kidney failure
- Liver failure
- Prior revascularisation
- Consecutive stenoses in a single artery
- Expected inability to complete the study protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-017014-80-NL |
| CCMO | NL30432.018.09 |