Skip to main content
OpenTrials
Completed

NCT Number: NCT02125526

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction No Reflow Persisting Ischemia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-Aortic Balloon Pump

Device

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

Primary outcomes

  1. Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure

    Time frame: 6 months

  2. All-cause mortality

    Time frame: 30 days and 6 months

Sponsors and collaborators

Lead sponsor

Lokien van Nunen

Other

Collaborators

  • Maquet Cardiovascular
  • Stichting Toegepaste Wetenschappen (project number 11052)

Registry information

Official study title

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

Acronym: SEMPER FI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2014
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.