PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00409604
First received: December 8, 2006
Last updated: August 30, 2010
Last verified: August 2010

December 8, 2006
August 30, 2010
December 2006
August 2009   (final data collection date for primary outcome measure)
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months [ Time Frame: 4 & 12 months ] [ Designated as safety issue: No ]
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
Complete list of historical versions of study NCT00409604 on ClinicalTrials.gov Archive Site
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PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
Device: Temporary RV VVI pacing
temporary pacing at the onset of revascularisation
  • Experimental: 1
    Standard PCI procedure + pacing post conditioning
    Intervention: Device: Temporary RV VVI pacing
  • No Intervention: 2
    Standard PCI procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Exclusion for MRI
  • Incapability of participating in exercise test
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00409604
CS1017-001
Not Provided
Racho Strauven, Guidant Europe
Guidant Corporation
Not Provided
Principal Investigator: JOhannes Waltenberger, Prof.Dr. University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
Guidant Corporation
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP