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Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia (SEMPER FI)

This study is currently recruiting participants.
Verified January 2017 by Lokien van Nunen, Catharina Ziekenhuis Eindhoven
Sponsor:
ClinicalTrials.gov Identifier:
NCT02125526
First Posted: April 29, 2014
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Stichting Toegepaste Wetenschappen (project number 11052)
Maquet Cardiovascular
Information provided by (Responsible Party):
Lokien van Nunen, Catharina Ziekenhuis Eindhoven
  Purpose

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 Intervention
Acute Myocardial Infarction Persisting Ischemia No Reflow Device: Intra-aortic balloon pump

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation

Resource links provided by NLM:


Further study details as provided by Lokien van Nunen, Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • IABP
  • Intra-aortic balloon counterpulsation
No Intervention: Control group
After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125526


Contacts
Contact: Nico H.J. Pijls, MD PhD +31 40 2397004 carias@cze.nl
Contact: Lokien X. van Nunen, MD +31 40 2397004 lokien.v.nunen@cze.nl

Locations
Netherlands
Catharina Hospital Recruiting
Eindhoven, Noord-Brabant, Netherlands, 5623EJ
Contact: Lokien X van Nunen, MD    +31 40 2397004    lokien.v.nunen@cze.nl   
Contact: Ingrid Aarts    +31 402397004    carias@cze.nl   
Principal Investigator: Nico HJ Pijls, MD PhD         
Sub-Investigator: Lokien X van Nunen, MD         
Sponsors and Collaborators
Lokien van Nunen
Stichting Toegepaste Wetenschappen (project number 11052)
Maquet Cardiovascular
Investigators
Principal Investigator: Nico H.J. Pijls, MD PhD Catharina Ziekenhuis Eindhoven
Principal Investigator: Lokien X van Nunen, MD Catharina Ziekenhuis Eindhoven
  More Information

Publications:
Responsible Party: Lokien van Nunen, MD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT02125526     History of Changes
Other Study ID Numbers: IABPinPI
STW-11052 ( Other Identifier: Stichting Toegepaste Wetenschappen )
First Submitted: April 24, 2014
First Posted: April 29, 2014
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Lokien van Nunen, Catharina Ziekenhuis Eindhoven:
Acute myocardial infarction
Persisting ischemia
No reflow
Intra-aortic balloon pump
Exhausted autoregulation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases