NCT00409604

Brief Summary

To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

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

Study Start

First participant enrolled

December 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

2.7 years

First QC Date

December 8, 2006

Last Update Submit

August 30, 2010

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months

    4 & 12 months

Study Arms (2)

1

EXPERIMENTAL

Standard PCI procedure + pacing post conditioning

Device: Temporary RV VVI pacing

2

NO INTERVENTION

Standard PCI procedure

Interventions

Temporary RV VVI pacingDEVICE

temporary pacing at the onset of revascularisation

1

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms
  • Total occlusion of a coronary artery with reference vessel diameter \>or= 3mm

You may not qualify if:

  • Thrombolitics
  • Severe bradycardia requiring cardiac pacing
  • Previous PCI or CABG
  • Recent stroke or CV surgery
  • Recent major surgery or trauma
  • Clinical and hemodynamic unstability
  • Implanted CRM device
  • Evidence of previous MI
  • Diabetes using rosiglitazone or other fibrates
  • Permanent AF
  • Mechanical tricuspid valve
  • Pregnancy
  • Incapability of participating in exercise test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Maastricht (azM)

Maastricht, Netherlands

Location

Related Publications (1)

  • Waltenberger J, Gelissen M, Bekkers SC, Vainer J, van Ommen V, Eerens F, Ruiters A, Holthuijsen A, Cuesta P, Strauven R, Mokelke E, Gorgels A, Prinzen FW. Clinical pacing post-conditioning during revascularization after AMI. JACC Cardiovasc Imaging. 2014 Jun;7(6):620-6. doi: 10.1016/j.jcmg.2014.01.017.

    PMID: 24925330DERIVED

Study Officials

  • JOhannes Waltenberger, Prof.Dr.

    University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2006

First Posted

December 11, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 31, 2010

Record last verified: 2010-08

Locations

NL(1)