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

NCT ID: NCT02125526

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-12-31

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.

Conditions

Acute Myocardial Infarction; Persisting Ischemia; No Reflow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IABP group

After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia

Group Type: ACTIVE_COMPARATOR

Intra-aortic balloon pump

Intervention Type: DEVICE

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.

Control group

After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

IABP; Intra-aortic balloon counterpulsation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stichting Toegepaste Wetenschappen (project number 11052)

UNKNOWN

Sponsor Role: collaborator

Maquet Cardiovascular

INDUSTRY

Sponsor Role: collaborator

Lokien van Nunen

OTHER

Sponsor Role: lead

Responsible Party

Lokien van Nunen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nico H.J. Pijls, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Lokien X van Nunen, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 24170231 (View on PubMed)

Other Identifiers

STW-11052

Identifier Type: OTHER

Identifier Source: secondary_id

IABPinPI

Identifier Type: -

Identifier Source: org_study_id