Phase None Completed NCT02233634

Impact of Breathing Maneuvers and Oxygen Administration on Myocardial Oxygenation in Patients With Coronary Artery Disease Compared With Healthy Controls - Non-invasive Assessment With Oxygenation-sensitive Cardiovascular Magnetic Resonance Imaging (OS-CMR)

Insel Gruppe AG, University Hospital Bern · Interventional, Non-randomized

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Coronary Artery Disease

Study context Single-site study No randomised comparison group

Overview

Patients with an impaired blood supply of the heart routinely receive oxygen in order to improve or preserve the oxygen supply of the heart muscle in acute cardiac care. In recent studies a new innovative MRI-technique that can detect changes in oxygen supply of the heart was able to show that the administration of oxygen or fast breathing can decrease the blood supply of the arteries supplying the heart muscle with oxygen. Thus, the administration of oxygen may paradoxically impair the oxygen supply of the heart muscle. In this study the investigators want to investigate, whether the administration of exogenous oxygen via a mask alone and in combination with fast breathing leads to a decrease in oxygen supply in regions with already impaired blood supply by a narrowing of a coronary artery of the heart.

Full record on ClinicalTrials.gov (NCT ID NCT02233634).

Results summary

None

Outcome data

Endpoint	Type	Result	Significance
Change of signal intensity (SI) in oxygenation-sensitive (OS) Cardiovascular Magnetic Resonance (CMR) during the breathing maneuvers/oxygen administration	Primary	None	None
Comparison of OS-SI changes between healthy and post-stenotic myocardium during the breathing-maneuvers/oxygen administration in CAD patients	Secondary	None	None
Comparison of OS-SI changes between healthy volunteers and and CAD patients during the breathing-maneuvers/oxygen administration	Secondary	None	None
Comparison between OS-SI changes during the breathing maneuvers/oxygen administration and results in quantitative coronary angiography in CAD patients (reduction of lumen diameter)	Secondary	None	None

Full results record on ClinicalTrials.gov.

Study design

Phase: Phase None
Study type: Interventional
Allocation: Non-randomizedⁱ
Masking: Single-blind
Intervention model: Factorial assignment
Primary purpose: Supportive Care
Enrollment (final): 36 participants
Started: October 2014
Actually completed: November 2017

Recruitment criteria

Age range: ≥ 18 · Sex: All · Healthy volunteers: Accepts

Locationsⁱ

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

Bern University Hospital — Bern (Switzerland)

Sources

REG

ClinicalTrials.gov — NCT02233634

Trial registry · primary record