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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Catharina Ziekenhuis Eindhoven
Sponsor:
Collaborators:
Stichting Toegepaste Wetenschappen (project number 11052)
Maquet Cardiovascular
Information provided by (Responsible Party):
Lokien van Nunen, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT02125526
First received: April 24, 2014
Last updated: July 3, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Intra-aortic Balloon Pump to Reduce Mortality in Extensive Myocardial Infarction With Persistent Ischemia; a Pilot Study

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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 Hospital Eindhoven
Principal Investigator: Lokien X van Nunen, MD Catharina Hospital 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
Study First Received: April 24, 2014
Last Updated: July 3, 2014
Health Authority: The Netherlands: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014