Acute Myocardial InfarctionSEMPER FINCT02125526
Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia
A study testing Intra-aortic balloon pump in people with Acute Myocardial Infarction and Persisting Ischemia, run by Lokien van Nunen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction, Persisting Ischemia, No Reflow
- What is being tested?
- Intra-aortic balloon pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to Dec 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Inability to provide informed consent
- Pregnancy
- Inability to perform coronary angiography by the femoral approach
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Myocardial Infarction, Persisting Ischemia, No Reflow
- Being tested
- Intra-aortic balloon pump
- Keywords
- Acute myocardial infarction, Persisting ischemia, No reflow, Intra-aortic balloon pump, Exhausted autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-aortic balloon pumpDevice
Also called IABP, Intra-aortic balloon counterpulsation
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.
| Study group | Role | What they receive |
|---|---|---|
| IABP group | Active comparator | After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia Receives: Device: Intra-aortic balloon pump |
| Control group | No intervention | After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure
Measured: 6 months
All-cause mortality
Measured: 30 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokien van Nunen
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Toegepaste Wetenschappen (project number 11052), Maquet Cardiovascular
- Responsible party
- Sponsor-investigator, Lokien van Nunen, Catharina Ziekenhuis Eindhoven
- Investigators
- Nico H.J. Pijls, MD PhD, Principal investigator, Catharina Ziekenhuis EindhovenLokien X van Nunen, MD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125526
- Sponsor's protocol ID
- IABPinPI
- Other IDs
- STW-11052
- Acronym
- SEMPER FI
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2014
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Nunen LX, van 't Veer M, Schampaert S, Steerneman BJ, Rutten MC, van de Vosse FN, Pijls NH. Intra-aortic balloon counterpulsation in acute myocardial infarction: old and emerging indications. Neth Heart J. 2013 Dec;21(12):554-60. doi: 10.1007/s12471-013-0485-9.
PubMed 24170231
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation
- ClinicalTrials.gov ID
- NCT02125526
- Acronym / sponsor ID
- SEMPER FI / IABPinPI
- Conditions
- Acute Myocardial Infarction, Persisting Ischemia, No Reflow
- Keywords
- Acute myocardial infarction, Persisting ischemia, No reflow, Intra-aortic balloon pump, Exhausted autoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lokien van NunenUniversity, hospital or other
- Collaborators
- Stichting Toegepaste Wetenschappen (project number 11052), Maquet Cardiovascular
- Study start
- Aug 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Apr 2014 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IABP group | Active comparator | Device: Intra-aortic balloon pumpAfter primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia |
| Control group | No intervention | –After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 pumpAlso: IABP, Intra-aortic balloon counterpulsationThe 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. | Device | IABP group |
Primary outcome
Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure
Time frame: 6 months
All-cause mortality
Time frame: 30 days and 6 months
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 2 May 2019.
- Background: PubMed 24170231van Nunen LX, van 't Veer M, Schampaert S, Steerneman BJ, Rutten MC, van de Vosse FN, Pijls NH. Intra-aortic balloon counterpulsation in acute myocardial infarction: old and emerging indications. Neth Heart J. 2013 Dec;21(12):554-60. doi: 10.1007/s12471-013-0485-9.
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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.
Nico H.J. Pijls, MD PhD principal investigator
Catharina Ziekenhuis Eindhoven
Lokien X van Nunen, MD principal investigator
Catharina Ziekenhuis Eindhoven
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 in people with Acute Myocardial Infarction and Persisting Ischemia, run by Lokien van Nunen at 1 site in Netherlands.
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 9 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 2 May 2019. 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 Netherlands. 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?
Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02125526, which also lists 1 linked publication.
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 2 May 2019.