The use of Helium in acute myocardial infarction trial (HAMI-trial).

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23814

Enrollment

Registered

2011-01-14

Start date

2011-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute myocardial infarction acute coronary syndrome ischemia reperfusion injury acuut hartinfarct acuut coronair syndroom ischemie reperfusie schade

Interventions

Helium inhalation (79%) starting directly after inclusion, untill 10 minutes after opening of the target vessel.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years; 2. ST-elevation myocardial infarction; 3. Treatment with primary PCI; 4. Chest pain of <12 hours duration.

Exclusion criteria

Exclusion criteria: 1. Left bundle branch block; 2. Previous myocardial infarction; 3. Fibrinolytic treatment in the previous 30 days; 4. Previous coronary artery bypass surgery; 5. Left main stenosis requiring coronary bypass surgery; 6. Severe heart failure as witnessed by any of the following: A. The need for mechanical ventilation; B. The use of an intra-aortic balloon pump or Impella; C. High catecholamine usage. 7. Usage of the anti-diabetic drug glibenclamide (this drug is known to block any conditioning effect); 8. Renal failure; 9. Inability to undergo MRI (e.g. due to the presence of pacemaker or ICD).

Design outcomes

Primary

Measure	Time frame
On day 4 after the PCI a CMR will be obtained. T-2 weighed imaging shows edema in the tissue which has been ischemic before and is therefore at risk for developing infarction. T-1 weighed imaging after the injection of gadolinium contrast marks the infarcted tissue. Primary endpoint is the total volume of infarction as proportion of the total volume of myocardium at risk.	—

Secondary

Measure	Time frame
CMR measurements: 1. On day 2-4: Left ventricular function, left ventricular dimensions, infarct size, edema; 2. After 4 months: Left ventricular function, left ventricular dimensions, infarct size; 3. Biomarker release following the PCI: Troponin T, NT-proBNP; 4. Time of ST-segment resolution after opening of the target vessel; 5. Thrombolysis in myocardial infarction (TIMI); 6. Grade Flow following opening of the target vessel; 7. Occurrence of death, re-infarction and admission for heart failure at 30 days and 4 months following PCI; 8. New York heart Association functional class at 30 days and 4 months following PCI.	—

Measure

Time frame

CMR measurements: 1. On day 2-4: Left ventricular function, left ventricular dimensions, infarct size, edema; 2. After 4 months: Left ventricular function, left ventricular dimensions, infarct size; 3. Biomarker release following the PCI: Troponin T, NT-proBNP; 4. Time of ST-segment resolution after opening of the target vessel; 5. Thrombolysis in myocardial infarction (TIMI); 6. Grade Flow following opening of the target vessel; 7. Occurrence of death, re-infarction and admission for heart failure at 30 days and 4 months following PCI; 8. New York heart Association functional class at 30 days and 4 months following PCI.

—

Contacts

Public ContactDaniel Brevoord

Postbus 22660, M0-126

d.brevoord@amc.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)