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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Guidant Corporation

Additional 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
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 October 02, 2014