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

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction; Persisting Ischemia; No Reflow
• Interventions: Device: Intra-aortic balloon pump

• Registration Number: NCT02125526
• Lead Sponsor: Lokien van Nunen

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.

Study Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Study Start: 2014-08
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IABP group	Intra-aortic balloon pump	After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia

Primary Outcome Measures

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

Trial Locations

Locations (1)

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands