Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04321434
Status:
TERMINATED
Last Update Posted:
2020-03-25
First Post:
2017-01-16
Brief Title:
Hyperoxia and Microvascular Dysfunction
Sponsor:
Université Libre de Bruxelles
Organization:
Université Libre de Bruxelles
Study Overview
Official Title:
Cardiac and Subcutaneous Microvascular Dysfunction in Patients With Ischemic Heart Disease Effects of an Acute Oxidative Stress
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease CAD pathophysiology involves endothelium-dependent eg nitric oxide acetylcholine and -independent eg 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
1 Endothelial dysfunction observed at the level of microvascular cardiac arteries is readily present at the level of subcutaneous microcirculation in a given CAD patient
2 An acute oxidative stress such as hyperoxia can be used to test myocardial microcirculatory dysfunction at the level of the more easily accessible subcutaneous microcirculation
3 Subcutaneous microcirculation of CAD patients has a lesser vasodilatory response to acetylcholine or sodium nipride than matched healthy subjects In addition CAD patients are more prone to dermal vasoconstriction in response to oxygen compared to healthy subjects
4 Taken that oxygen is still too often given in excess in most clinical settings the aim of this study is to rule out possible pitfalls in coronary pressure and resistance determinations in CAD patients receiving unnecessary oxygen supplementation
1 Endothelial dysfunction observed at the level of microvascular cardiac arteries is readily present at the level of subcutaneous microcirculation in a given CAD patient
2 An acute oxidative stress such as hyperoxia can be used to test myocardial microcirculatory dysfunction at the level of the more easily accessible subcutaneous microcirculation
3 Subcutaneous microcirculation of CAD patients has a lesser vasodilatory response to acetylcholine or sodium nipride than matched healthy subjects In addition CAD patients are more prone to dermal vasoconstriction in response to oxygen compared to healthy subjects
4 Taken that oxygen is still too often given in excess in most clinical settings the aim of this study is to rule out possible pitfalls in coronary pressure and resistance determinations in CAD patients receiving unnecessary oxygen supplementation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None