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

Condition Intervention Phase
Acute Myocardial Infarction Device: Temporary RV VVI pacing Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: December 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Standard PCI procedure + pacing post conditioning
Device: Temporary RV VVI pacing
temporary pacing at the onset of revascularisation
No Intervention: 2
Standard PCI procedure

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409604


Locations
Netherlands
University Hospital of Maastricht (azM)
Maastricht, Netherlands
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: JOhannes Waltenberger, Prof.Dr. University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Racho Strauven, Guidant Europe
ClinicalTrials.gov Identifier: NCT00409604     History of Changes
Other Study ID Numbers: CS1017-001
First Submitted: December 8, 2006
First Posted: December 11, 2006
Last Update Posted: August 31, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases