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Completed

NCT Number: NCT00469248

Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock

The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial infarction with shock is not established. We hypothesised that use of such a device would lead to improved outcomes in these patients.

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Key information

Conditions

Myocardial Infarction Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Inflammation Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Systemic Inflammatory Response Syndrome Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine III, Klinikum Krollwitz, Martin Luther University

Halle, Saxony-Anhalt, 06120, Germany

About this study

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) with cardiogenic shock (CS) are often treated with Intra-aortic balloon pump counterpulsation (IABP) although the evidence to support this is limited. We conducted a prospective, randomised clinical trial, of IABP as an addition to PCI centred therapy, in patients with AMI complicated by CS.

45 patients with AMI and CS undergoing PCI were randomised to care with or without IABP. Over 4 days, APACHE II scores, haemodynamic parameters, inflammatory markers and BNP levels were collected to assess the impact of IABP treatment on CS triggered multi organ dysfunction syndrome (MODS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute myocardial infarction
  • Cardiogenic shock

Exclusion criteria

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction

Treatment and study plan

Intra-aortic balloon pump counterpulsation

Device

Primary outcomes

  1. APACHE II SCORE

    Time frame: 4 days

Secondary outcomes

  1. Haemodynamic state

    Time frame: 4 days

  2. BNP levels

    Time frame: 4 days

  3. Inflammatory activation

    Time frame: 4 days

  4. Mortality

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

Intra-Aortic Balloon Counterpulsation in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock - The Prospective, Randomised IABP SHOCK Trial for Attenuation of Multi-Organ Dysfunction Syndrome

Acronym: IABPSHOCK

Important dates

Study start
2003
Study completion
2004
First posted
May 4, 2007
Registry last updated
May 4, 2007

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.

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