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Hyperoxia and Microvascular Dysfunction

Cardiac and Subcutaneous Microvascular Dysfunction in Patients With Ischemic Heart Disease: Effects of an Acute Oxidative Stress

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04321434
Enrollment
10
Registered
2020-03-25
Start date
2016-12-01
Completion date
2018-10-01
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Microvascular Disease, Microvascular Disease, Ischemic Heart Disease

Keywords

cardiac microvascular dysfunction, subcutaneous microvascular dysfunction, ischemic heart disease, oxydative stress

Brief summary

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: 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.

Interventions

OTHERHyperoxia

laser Doppler

Sponsors

Université Libre de Bruxelles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Coronary angiography done in the context of suspicion of coronary artery disease (CAD)

Exclusion criteria

* Respiratory failure requiring intubation or supplementary oxygen * Severe chronic obstructive pulmonary disease * Significant arrhythmia precluding waveform analysis (e.g., excessive premature ventricular contractions or atrial fibrillation) * Severe valvular heart disease, * Suspected elevated central venous pressure (CVP) * Heart failure as defined by New York Heart Association class III or IV * Previous coronary revascularization or heart transplantation * Severe hypertension (systolic pressure \>200 mmHg and diastolic pressure \>120 mmHg at rest) * Contraindications to adenosine infusion * Contraindication to acetylcholine (Ach) infusion * Severe bronchial asthma.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in the acetylcholine-induced skin blood flow after hyperoxia1 hourMeasurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Change from baseline in the sodium nitroprusside-induced skin blood flow after hyperoxia1 hourMeasurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Change from baseline in the heat-induced skin blood flow after hyperoxia1 hourMeasurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Change from Baseline in the index of microcirculatory resistance Under adenosine after hyperoxia10 minutesMeasurement of coronary microcirculatory resistance (index of microcirculatory resistance) Under adenosine before and after hyperoxia, expressed in arbitrary units
Change from Baseline in the index of microcirculatory resistance at rest after hyperoxia10 minutesMeasurement of coronary microcirculatory resistance (index of microcirculatory resistance) at rest before and after hyperoxia, expressed in arbitrary units

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026