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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409604
First Posted: December 11, 2006
Last Update Posted: August 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guidant Corporation
December 8, 2006
December 11, 2006
August 31, 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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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
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.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00409604
CS1017-001
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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