Myocardial InfarctionIABPSHOCKNCT00469248
Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock
A study testing Intra-aortic balloon pump counterpulsation in people with Myocardial Infarction and Cardiogenic Shock, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, Cardiogenic Shock
- What is being tested?
- Intra-aortic balloon pump counterpulsation
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute myocardial infarction
- Cardiogenic shock
Who cannot join
- Absent peripheral pulses
- Mechanical complications of myocardial infarction
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine III, Klinikum Krollwitz, Martin Luther University
Halle, Saxony-Anhalt, 06120
About this study
Official 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
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.
Read the detailed description
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).
- Conditions
- Myocardial Infarction, Cardiogenic Shock
- Being tested
- Intra-aortic balloon pump counterpulsation
- Keywords
- Myocardial infarction, Cardiogenic shock, Systemic inflammatory response syndrome, Percutaneous coronary intervention, aortic balloon counterpulsation
- Medical subject headings
- Myocardial Infarction, Shock, Cardiogenic, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-aortic balloon pump counterpulsationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
APACHE II SCORE
Measured: 4 days
Secondary outcomes (4)
Haemodynamic state
Measured: 4 days
BNP levels
Measured: 4 days
Inflammatory activation
Measured: 4 days
Mortality
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMar 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Investigators
- Michael Buerke, MD, Study chair, Martin Luther UniversityRoland Prondzinsky, MD, Principal investigator, Martin Luther University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469248
- Sponsor's protocol ID
- MLU-IABPSHOCK
- Acronym
- IABPSHOCK
- Status last verified
- Apr 2007
- First submitted
- 3 May 2007
- Last updated
- 4 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Prondzinsky R, Unverzagt S, Lemm H, Wegener N, Heinroth K, Buerke U, Fiedler M, Thiery J, Haerting J, Werdan K, Buerke M. Acute myocardial infarction and cardiogenic shock: prognostic impact of cytokines: INF-gamma, TNF-alpha, MIP-1beta, G-CSF, and MCP-1beta. Med Klin Intensivmed Notfmed. 2012 Sep;107(6):476-84. doi: 10.1007/s00063-012-0117-y. Epub 2012 Jul 20.
PubMed 22810435Prondzinsky R, Unverzagt S, Russ M, Lemm H, Swyter M, Wegener N, Buerke U, Raaz U, Ebelt H, Schlitt A, Heinroth K, Haerting J, Werdan K, Buerke M. Hemodynamic effects of intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP shock trial. Shock. 2012 Apr;37(4):378-84. doi: 10.1097/SHK.0b013e31824a67af.
PubMed 22266974Prondzinsky R, Unverzagt S, Lemm H, Wegener NA, Schlitt A, Heinroth KM, Dietz S, Buerke U, Kellner P, Loppnow H, Fiedler MG, Thiery J, Werdan K, Buerke M. Interleukin-6, -7, -8 and -10 predict outcome in acute myocardial infarction complicated by cardiogenic shock. Clin Res Cardiol. 2012 May;101(5):375-84. doi: 10.1007/s00392-011-0403-3. Epub 2012 Jan 3.
PubMed 22212516Prondzinsky R, Lemm H, Swyter M, Wegener N, Unverzagt S, Carter JM, Russ M, Schlitt A, Buerke U, Christoph A, Schmidt H, Winkler M, Thiery J, Werdan K, Buerke M. Intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP SHOCK Trial for attenuation of multiorgan dysfunction syndrome. Crit Care Med. 2010 Jan;38(1):152-60. doi: 10.1097/CCM.0b013e3181b78671.
PubMed 19770739
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00469248
- Acronym / sponsor ID
- IABPSHOCK / MLU-IABPSHOCK
- Conditions
- Myocardial Infarction, Cardiogenic Shock
- Keywords
- Myocardial infarction, Cardiogenic shock, Systemic inflammatory response syndrome, Percutaneous coronary intervention, aortic balloon counterpulsation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Jun 2004 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myocardial infarction
- Cardiogenic shock
Key exclusion criteria (2 listed)
- Absent peripheral pulses
- Mechanical complications of myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-aortic balloon pump counterpulsation | Device | – |
Primary outcome
APACHE II SCORE
Time frame: 4 days
4 secondary outcomes
Haemodynamic state
Time frame: 4 days
BNP levels
Time frame: 4 days
Inflammatory activation
Time frame: 4 days
Mortality
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2007.
- Derived from this study: PubMed 22810435Prondzinsky R, Unverzagt S, Lemm H, Wegener N, Heinroth K, Buerke U, Fiedler M, Thiery J, Haerting J, Werdan K, Buerke M. Acute myocardial infarction and cardiogenic shock: prognostic impact of cytokines: INF-gamma, TNF-alpha, MIP-1beta, G-CSF, and MCP-1beta. Med Klin Intensivmed Notfmed. 2012 Sep;107(6):476-84. doi: 10.1007/s00063-012-0117-y. Epub 2012 Jul 20.
- Derived from this study: PubMed 22266974Prondzinsky R, Unverzagt S, Russ M, Lemm H, Swyter M, Wegener N, Buerke U, Raaz U, Ebelt H, Schlitt A, Heinroth K, Haerting J, Werdan K, Buerke M. Hemodynamic effects of intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP shock trial. Shock. 2012 Apr;37(4):378-84. doi: 10.1097/SHK.0b013e31824a67af.
- Derived from this study: PubMed 22212516Prondzinsky R, Unverzagt S, Lemm H, Wegener NA, Schlitt A, Heinroth KM, Dietz S, Buerke U, Kellner P, Loppnow H, Fiedler MG, Thiery J, Werdan K, Buerke M. Interleukin-6, -7, -8 and -10 predict outcome in acute myocardial infarction complicated by cardiogenic shock. Clin Res Cardiol. 2012 May;101(5):375-84. doi: 10.1007/s00392-011-0403-3. Epub 2012 Jan 3.
- Derived from this study: PubMed 19770739Prondzinsky R, Lemm H, Swyter M, Wegener N, Unverzagt S, Carter JM, Russ M, Schlitt A, Buerke U, Christoph A, Schmidt H, Winkler M, Thiery J, Werdan K, Buerke M. Intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP SHOCK Trial for attenuation of multiorgan dysfunction syndrome. Crit Care Med. 2010 Jan;38(1):152-60. doi: 10.1097/CCM.0b013e3181b78671.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Buerke, MD study chair
Martin Luther University
Roland Prondzinsky, MD principal investigator
Martin Luther University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-aortic balloon pump counterpulsation in people with Myocardial Infarction and Cardiogenic Shock, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APACHE II SCORE (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469248, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2007.