Research with human participants

Overview of medical research in the Netherlands

A multicenter randomized controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size pre PCI for acute myocardial infarction- CRISP-AMI.

Published:
Last updated:

To investigate if infarct size can be limited by introduction of IABP prior to intervention.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Myocardial disorders
Study type
Interventional

ID

NL-OMON33290

Source

ToetsingOnline

Brief title

CRISP-AMI

Condition

  • Myocardial disorders

Synonym

Acute anterior wall myocardial infarction

Research involving

Human

Sponsors and support

Primary sponsor :
Datascope BV
Source(s) of monetary or material Support :
De industrie

Intervention

Keyword :
Anterior wall myocardial infarction, Infarct size., Intra aortic balloonpumping

Outcome measures

Primary outcome

Infarct size, measured by MRI after 3-5 days.

Secondary outcome

- Left ventricle function + dimensions investigated by MRI and Echo/doppler

parameters

- Resolution of ST-elevation on the ECG

Background summary

During primary percutaneous coronary intervention (PPCI) for acute myocarial
infarction, reperfusion injury may occur.
This injury can be possibly limited by previous introduction of an intra-aortic
balloon pump (IABP) prior to PPCI.

Study objective

To investigate if infarct size can be limited by introduction of IABP prior to
intervention.

Study design

Randomized controlled multicenter study in 300 patients.

Intervention

Introduction of IABP prior to the PPCI in the patients randomized to IABP.

Study burden and risks

- Controlateral arterial puncture in the patients of the IABP group.
- MRI of the heart after 3-5 days in all patients.

Public
Datascope BV

Drs. W. van Royenstraat 8
3871 AW Hoevelaken
NL
Scientific
Datascope BV

Drs. W. van Royenstraat 8
3871 AW Hoevelaken
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Patients between the age of 18-90 years old with an acute anterior wall myocardial infarction and presenting in the hospital within 6 hours of onset of complaints.

Exclusion criteria

- Cardiogenic shock
- previous bypass surgery
- previous myocardial infarction
- known contraindication for MRI

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Prevention

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
20
Type :
Actual

Medical products/devices used

Generic name :
Intra aortic balloonpump (IABP)
Registration
:
Yes - CE intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

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
Other DUHS elRB registry CR1_Pro00011992
CCMO NL29245.060.09