NCT04321434

Hyperoxia and Microvascular Dysfunction

Terminated NA Last updated 25 March 2020

What this trial tests

NA trial testing Hyperoxia in Coronary Microvascular Disease in 10 participants. Terminated before completion.

Timeline

1 December 2016

Primary endpoint
1 April 2018

1 October 2018

Quick facts

Lead sponsor	Université Libre de Bruxelles
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	10
Start date	1 December 2016
Primary completion	1 April 2018
Estimated completion	1 October 2018
Sites	1 location across Belgium

Drugs / interventions tested

• Hyperoxia — full drug profile →
• Normoxia
• laser Doppler

Conditions studied

• Coronary Microvascular Disease — all drugs for Coronary Microvascular Disease →
• Microvascular Disease — all drugs for Microvascular Disease →
• Ischemic Heart Disease — all drugs for Ischemic Heart Disease →

Sponsor

Université Libre de Bruxelles — full company profile →

Who can join

Adults 18 to 85, any sex, with Coronary Microvascular Disease or Microvascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.