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Futility
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Coronary artery disease (CAD) pathophysiology involves endothelium-dependent (e.g. nitric oxide, acetylcholine) and -independent (e.g. adenosine) vascular dilation impairment, which have been demonstrated at the level of small coronary arteries, medium sized peripheral arteries and subcutaneous microcirculation. Oxygen supplementation, which is frequently overused in clinical settings, seems harmful in acute coronary syndromes and increases microvascular resistance in myocardial and subcutaneous microcirculation through alteration of endothelium-dependent and -independent dilation by an oxidative mechanism. Whether endothelial dysfunction, that is well documented at the level of cardiac microcirculation in CAD patients, is also present at the level of subcutaneous microcirculation is unknown. Also, unknown is whether an acute oxidative stress can be used to probe myocardial microcirculatory dysfunction at the level of subcutaneous microcirculation, which is an easily accessible vascular bed for an in vivo assessment of endothelial-dependent and-independent function. Alterations in cutaneous vascular signalling are evident early in the disease processes. Thus, studying subcutaneous circulation in patients with cardiovascular risk factors could provide vascular information early in CAD processes. This study will test the following 4 hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperoxia | Experimental |
|
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| Normoxia | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperoxia | Other |
| ||
| Normoxia |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the acetylcholine-induced skin blood flow after hyperoxia | Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units). | 1 hour |
| Change from baseline in the sodium nitroprusside-induced skin blood flow after hyperoxia | Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units). | 1 hour |
| Change from baseline in the heat-induced skin blood flow after hyperoxia | Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units). | 1 hour |
| Change from Baseline in the index of microcirculatory resistance Under adenosine after hyperoxia | Measurement of coronary microcirculatory resistance (index of microcirculatory resistance) Under adenosine before and after hyperoxia, expressed in arbitrary units | 10 minutes |
| Change from Baseline in the index of microcirculatory resistance at rest after hyperoxia | Measurement of coronary microcirculatory resistance (index of microcirculatory resistance) at rest before and after hyperoxia, expressed in arbitrary units | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Van Vooren, MD, PhD | Hospital Erasme | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Brussels | Brabant | 1070 | Belgium |
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| ID | Term |
|---|---|
| D017566 | Microvascular Angina |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017078 | Laser-Doppler Flowmetry |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012212 | Rheology |
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|
| laser Doppler | Device | laser Doppler |
|
| D008919 | Investigative Techniques |