Acute Myocardial Infarction Clinical Trial
— SEMPER FIOfficial title:
Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation
Verified date | April 2019 |
Source | Catharina Ziekenhuis Eindhoven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Catharina Hospital | Eindhoven | Noord-Brabant |
Lead Sponsor | Collaborator |
---|---|
Lokien van Nunen | Maquet Cardiovascular, Stichting Toegepaste Wetenschappen (project number 11052) |
Netherlands,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure | 6 months | ||
Primary | All-cause mortality | 30 days and 6 months |
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