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

• Conditions: Coronary artery disease; MedDRA version: 12.0Level: PTClassification code 10011078Term: Coronary artery disease

• Registration Number: EUCTR2009-017014-80-NL
• Lead Sponsor: Academical Medical Center, University of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified