Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia (SEMPER FI)
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|ClinicalTrials.gov Identifier: NCT02125526|
Recruitment Status : Recruiting
First Posted : April 29, 2014
Last Update Posted : February 21, 2018
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.
|Condition or disease||Intervention/treatment|
|Acute Myocardial Infarction Persisting Ischemia No Reflow||Device: Intra-aortic balloon pump|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: IABP group
After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia
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.
No Intervention: Control group
After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines
- Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure [ Time Frame: 6 months ]
- All-cause mortality [ Time Frame: 30 days and 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125526
|Contact: Nico H.J. Pijls, MD PhD||+31 40 firstname.lastname@example.org|
|Contact: Lokien X. van Nunen, MD||+31 40 email@example.com|
|Eindhoven, Noord-Brabant, Netherlands, 5623EJ|
|Contact: Lokien X van Nunen, MD +31 40 2397004 firstname.lastname@example.org|
|Contact: Ingrid Aarts +31 402397004 email@example.com|
|Principal Investigator: Nico HJ Pijls, MD PhD|
|Sub-Investigator: Lokien X van Nunen, MD|
|Principal Investigator:||Nico H.J. Pijls, MD PhD||Catharina Ziekenhuis Eindhoven|
|Principal Investigator:||Lokien X van Nunen, MD||Catharina Ziekenhuis Eindhoven|