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

Acute Myocardial Infarction Clinical Trial

— SEMPER FI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125526
• Other study ID #: IABPinPI
• Secondary ID: STW-11052
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Ischemia
• Myocardial Infarction
• No Reflow
• Persisting Ischemia

Intervention

Device:
• Intra-aortic balloon pump
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.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Lokien van Nunen	Maquet Cardiovascular, Stichting Toegepaste Wetenschappen (project number 11052)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure		6 months
Primary	All-cause mortality		30 days and 6 months