The effect of helium inhalation on the coronary circulation and vessel diameter - Helium and the coronary circulation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017014-80-NL

Enrollment

Registered

2009-11-30

Start date

2010-02-22

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Coronary artery disease MedDRA version: 12.0 Level: PT Classification code 10011078 Term: Coronary artery disease

Interventions

Trade Name: Heliox Pharmaceutical Form: Inhalation gas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Elective PCI - Age 18-80 years - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Acute coronary syndrome - Cardiogenic shock - Prior coronary artery bypass grafting (CABG) - Presence of a significant left main coronary artery stenosis (> 50% diameter stenosis) - Diffuse disease - Diabetes - Severe pulmonary disease - Kidney failure - Liver failure - Prior revascularisation - Consecutive stenoses in a single artery - Expected inability to complete the study protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of helium inhalation on the coronary circulation and vessel diameter. ;Secondary Objective: N.a.;Primary end point(s): - Coronary flow reserve (CFR) in the LAD	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026