The aim of this clinical study is to investigate whether the non-anaesthetic noble gas helium induces EPC and LPC of human endothelium in vivo.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Endothelial preconditioning with helium will
be investi¬gated by measurement of forearm blood flow using the venous
occlusion plethysmography model. Primary end-point is blood flow and reactive
hyperemia before and after I/R with or without helium inhalation after
stimulation with either serotonin (5HT) as an endothelium-dependent or sodium
nitroprusside (SNP) as an endothelium-independent vasodilator.
Secondary outcome
Secondary parameters will be measurement as endothelial adhesion molecules on
leukocytes. Therefore, blood samples will be collected at different time
points.
Background summary
Supported by experimental and clinical data showing reduction of endothelial
cell damage by noble gases in human umbilical vein endothelial cells as well as
by subanesthetic concentrations of sevoflurane in humans subjected to
ischemia-reperfusion, we hypothesize that the noble gas helium induces early
(EPC) and late (LPC) preconditioning in human endothelium in vivo.
Study objective
The aim of this clinical study is to investigate whether the non-anaesthetic
noble gas helium induces EPC and LPC of human endothelium in vivo.
Study design
single center, randomized, open label, observational study. In this combined
clinical-laboratory investigation, investigators of laboratory parameters will
be blinded. Blinding of the patient is not possible as the patient will
recognize changes in voice (shortly higher voice during helium inhalation) and
therefore will know that she/he inhales helium.
Study population: healthy human volunteers, 18 - 65 yr old
Intervention
We will compare a control group (group 1, CON) to volunteers who will undergo
ischemia and reperfusion of the forearm in the absence (group 2, I/R) or
presence of helium inhalation (3*5 min, 79%) 15 min (group 3, EPC) or 24 hours
(group 4, LPC) before forearm ischemia. Another group will undergo ischemic
preconditioning and will serve as positive control (group 5, IPC).
Study burden and risks
Volunteers will undergo helium inhalation (79% helium, 21% oxygen), which has
until now not reported to have no relevant cardiovascular, pulmonary, allergic
or other side effects. A gas-mixture of helium with oxygen (heliox) is already
in clinical use for patients with severe asthma or for children undergoing
mechanical ventilation. Volunteers will experience a transiently higher voice
after helium inhalation. Cannulation of an artery as well as venous access
lines will be placed under local anesthesia and aseptic conditions (best
clinical practice procedures). Four to five blood samples (10 ml each) will be
drawn from inserted cannulas. Participation will include a whole day and a
telephone interview the following day. Patients undergoing LPC have to come to
the AMC one day before the measurements will take place to inhale 3*5 min
helium 79% / oxygen 21%. On the day of participation, a physical examination
(cardiopulmonary system) will be performed by a physician.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers aged 18-65 years, informed consent
Exclusion criteria
untreated arterial hypertension, known renal impairment, liver disease, cardiovascular disease (arterial hypertension, angina, previous myocardial infarction, history of stroke), history of diabetes mellitus, coagulatopathy (PTT > 1.5 times control), anti coagulation drugs, antihypertensive drugs, contra indication or intolerance to any used substance
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 | EUCTR2007-006233-14-NL |
| CCMO | NL20607.018.07 |