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Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia (SEMPER FI)

Primary Purpose

Acute Myocardial Infarction, Persisting Ischemia, No Reflow

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intra-aortic balloon pump
Sponsored by
Lokien van Nunen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Persisting ischemia, No reflow, Intra-aortic balloon pump, Exhausted autoregulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catharina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

IABP group

Control group

Arm Description

After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia

After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines

Outcomes

Primary Outcome Measures

Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure
All-cause mortality

Secondary Outcome Measures

Full Information

First Posted
April 24, 2014
Last Updated
April 30, 2019
Sponsor
Lokien van Nunen
Collaborators
Stichting Toegepaste Wetenschappen (project number 11052), Maquet Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT02125526
Brief Title
Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia
Acronym
SEMPER FI
Official Title
Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lokien van Nunen
Collaborators
Stichting Toegepaste Wetenschappen (project number 11052), Maquet Cardiovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Persisting Ischemia, No Reflow
Keywords
Acute myocardial infarction, Persisting ischemia, No reflow, Intra-aortic balloon pump, Exhausted autoregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IABP group
Arm Type
Active Comparator
Arm Description
After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia
Arm Title
Control group
Arm Type
No Intervention
Arm Description
After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines
Intervention Type
Device
Intervention Name(s)
Intra-aortic balloon pump
Other Intervention Name(s)
IABP, Intra-aortic balloon counterpulsation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure
Time Frame
6 months
Title
All-cause mortality
Time Frame
30 days and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nico H.J. Pijls, MD PhD
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lokien X van Nunen, MD
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623EJ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24170231
Citation
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.
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Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia

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