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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02125526
Other study ID # IABPinPI
Secondary ID STW-11052
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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