Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia

NCT02125526 — Not applicable, Completed, 100 participants, Lokien van Nunen

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Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation

Registry	NCT02125526, acronym SEMPER FI
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Actual)
Sponsor	Lokien van Nunen (Other); collaborators: Stichting Toegepaste Wetenschappen (project number 11052), Maquet Cardiovascular
Conditions	Acute Myocardial Infarction, Persisting Ischemia, No Reflow
Interventions	Intra-aortic balloon pump (Device)
Dates	start 2014-08-01, primary completion 2018-12-01, completion 2018-12-01, first posted 2014-04-29, last updated 2019-05-02
Locations	1 site in Netherlands

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
IABP group	Active comparator	Device: Intra-aortic balloon pump	After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia
Control group	No intervention		After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines

Intra-aortic balloon pump (Device), also known as IABP, Intra-aortic balloon counterpulsation: The intra-aortic balloon pump is placed in the descending thoracic aorta and inflates and deflates in synchrony with the cardiac cycle, providing diastolic augmentation and improving coronary blood flow, while deflating before systole, providing afterload and workload reduction for the myocardium.

+Outcome measures

Primary outcomes

Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure [6 months]
All-cause mortality [30 days and 6 months]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Catharina Hospital	Eindhoven, North Brabant	Netherlands

+Publications

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. PMID 24170231

+Investigators

Nico H.J. Pijls, MD PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
Lokien X van Nunen, MD, Principal investigator, Catharina Ziekenhuis Eindhoven