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

April 30, 2019 updated by: Lokien van Nunen

Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623EJ
        • Catharina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure
Time Frame: 6 months
6 months
All-cause mortality
Time Frame: 30 days and 6 months
30 days and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lokien van Nunen

Collaborators

Maquet Cardiovascular
Stichting Toegepaste Wetenschappen (project number 11052)

Investigators

  • Principal Investigator: Nico H.J. Pijls, MD PhD, Catharina Ziekenhuis Eindhoven
  • Principal Investigator: Lokien X van Nunen, MD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IABPinPI
  • STW-11052 (Other Identifier: Stichting Toegepaste Wetenschappen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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