To test if IABP therapy is useful in patients presenting with large acute myocardial infarction complicated by persistent ischemia (no-reflow).
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mortality, development of heart failure within six months necessitating
hospital admission, and necessity for mechanical hemodynamic support
Secondary outcome
None.
Background summary
Patients presenting with large myocardial infarction and poor hemodynamic
condition after succesful stenting, have a poor prognosis with respect to
outcome and development of heart failure in the future. In some of these
patients, IABP is very effective, in others it is not.
Our hypothesis is that in patients in whom persistent ischemia is present (as
represented by insufficient ST-segment resolution on the ECG) IABP will be
beneficial; whereas in patients with pumpfailure without persistent ischemia,
IABP is of little value.
Study objective
To test if IABP therapy is useful in patients presenting with large acute
myocardial infarction complicated by persistent ischemia (no-reflow).
Study design
Open randomised pilot study in 100 patients fulfilling the inclusion criteria.
Intervention
Placement of an intra-aortic balloon pump (IABP)
Study burden and risks
There is only a neglectable extra risk or burden for the patients compared with
regular treatment.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
- Age 18 * 80 years old
- 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 >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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02125526 |
| CCMO | NL48245.060.14 |