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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:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00409604
First received: December 8, 2006
Last updated: August 30, 2010
Last verified: August 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Racho Strauven, Guidant Europe
ClinicalTrials.gov Identifier: NCT00409604     History of Changes
Other Study ID Numbers: CS1017-001
Study First Received: December 8, 2006
Last Updated: August 30, 2010
Health Authority: Netherlands: Dutch Health Care Inspectorate

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

ClinicalTrials.gov processed this record on May 19, 2013