NCT02125526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

4.3 years

First QC Date

April 24, 2014

Last Update Submit

April 30, 2019

Conditions

Acute Myocardial InfarctionPersisting IschemiaNo Reflow

Keywords

Acute myocardial infarctionPersisting ischemiaNo reflowIntra-aortic balloon pumpExhausted autoregulation

Outcome Measures

Primary Outcomes (2)

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

    6 months

  • All-cause mortality

    30 days and 6 months

Study Arms (2)

IABP group

ACTIVE COMPARATOR

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

Device: Intra-aortic balloon pump

Control group

NO INTERVENTION

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

Interventions

Intra-aortic balloon pumpDEVICE

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.

Also known as: IABP, Intra-aortic balloon counterpulsation
IABP group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24170231BACKGROUND

MeSH Terms

Interventions

Intra-Aortic Balloon Pumping

Intervention Hierarchy (Ancestors)

CounterpulsationAssisted CirculationSurgical Procedures, Operative

Study Officials

  • Nico H.J. Pijls, MD PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • Lokien X van Nunen, MD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 29, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

NL(1)