Does helium protect the heart against ischaemia-reperfusion damage in patients with acute myocardial infarction? - Helium-MI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022393-13-NL

Enrollment

Registered

2010-08-12

Start date

2010-11-24

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

Acute myocardial infarction MedDRA version: 12.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction MedDRA version: 12.1 Level: LLT Classification code 10051624 Term: Myocardial reperfusion injury MedDRA version: 12.1 Level: LLT Classification code 10063837 Term: Reperfusion injury

Interventions

Trade Name: Heliox Pharmaceutical Form: Inhalation gas Pharmaceutical form of the placebo: Inhalation gas Route of administration of the placebo: Inhalation use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-75 ST-elevation myocardial infarction, which will be treated by primary PCI Chest pain of less then 12 hours duration 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: Left bundle branch block Previous MI Fibrinolytic treatment in the previous 30 days Prior coronary artery bypass grafting surgery Left main stenosis, requiring coronary artery bypass grafting surgery Severe heart failure, as witnessedby any of the folowing: need for mechinal ventilation, need for an intra-aortic balloon bup or Impella, or the need of high dosage of catechomalines Use of glibenclamide Kidney failure A contraindication for MRI

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether helium inhalation during primary PCI as treatment for an acute myocardial infarction reduces the infarct size as percentage of the area at risk, as measured by cardiac magentic resonance imaging. ;Secondary Objective: To investigate whether helium inhalation during primary PCI as treatment for an acute myocardial infarction: - reduces the time for ST-segment resolution - reduces pain and/or discomfort during PCI - improves myocardial function (volumes and ejection fraction) - reduces biomarker release (troponin T, NT-proBNP) - reduces adverse cardiovascular events the first 4 months following PCI;Primary end point(s): Infarct size, as measured by cardiac MRI and related to the area at risk (the amount of edema on T-2 weighed images).	—

Measure

Time frame

Main Objective: To investigate whether helium inhalation during primary PCI as treatment for an acute myocardial infarction reduces the infarct size as percentage of the area at risk, as measured by cardiac magentic resonance imaging. ;Secondary Objective: To investigate whether helium inhalation during primary PCI as treatment for an acute myocardial infarction: - reduces the time for ST-segment resolution - reduces pain and/or discomfort during PCI - improves myocardial function (volumes and ejection fraction) - reduces biomarker release (troponin T, NT-proBNP) - reduces adverse cardiovascular events the first 4 months following PCI;Primary end point(s): Infarct size, as measured by cardiac MRI and related to the area at risk (the amount of edema on T-2 weighed images).

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Countries

Netherlands

Outcome results

None listed

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