Clinical trial NCT02125526: Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia
Official title: Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Persisting Ischemia
No Reflow
Keywords: Acute myocardial infarction
Persisting ischemia
No reflow
Intra-aortic balloon pump
Exhausted autoregulation
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Stichting Toegepaste Wetenschappen (project number 11052)
name: Maquet Cardiovascular
First posted: 2014-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presenting with large myocardial infarction and signs of persistent ischemia after successful percutaneous coronary intervention, have a poor prognosis with respect to outcome and development of heart failure in the future.

The hypothesis of this study is that in patients in whom persistent ischemia is present, use of intra-aortic balloon pump will be beneficial and improve outcome.

Detailed description: In some patients presenting with large myocardial infarction and poor hemodynamic condition, intra-aortic balloon counterpulsation is effective in alleviating cardiogenic shock. In others, the use of intra-aortic balloon pump has no effect at all. The investigators believe this is dependent on the presence of persisting ischemia after successful epicardial reperfusion, known as no-reflow.

In the presence of persisting ischemia, the investigators believe us of the intra-aortic balloon pump will relieve ischemia and improve outcome.

Eligibility criteria: Inclusion Criteria:

* Acute ST-segment elevation myocardial infarction with summed ST-segment deviation ≥15 mm.
* Insufficient ST-segment resolution (\<50%) on the ECG made 10-30 minutes after the primary PCI in the catheterization laboratory.

Exclusion Criteria:

* Initial summed ST-segment deviation less than 15 mm
* ST-segment resolution \> 50% on the ECG performed in the catheterization laboratory
* Chest pain onset less than 2 or more than 8 hours before arrival
* Severe aortic valve stenosis/regurgitation
* Aortic abnormalities prohibitive for use of intra aortic balloon pump
* Full blown cardiogenic shock with immediate requirement of left ventricular assist device as judged necessary by the operator
* Inability to provide informed consent
* Pregnancy
* Inability to perform coronary angiography by the femoral approach

Primary outcomes:
measure: Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 30 days and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Nico H.J. Pijls, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Lokien X van Nunen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Nunen LX, van 't Veer M, Schampaert S, Steerneman BJ, Rutten MC, van de Vosse FN, Pijls NH. Intra-aortic balloon counterpulsation in acute myocardial infarction: old and emerging indications. Neth Heart J. 2013 Dec;21(12):554-60. doi: 10.1007/s12471-013-0485-9.