PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Temporary RV VVI pacing
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility 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
Sites / Locations
- University Hospital of Maastricht (azM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Standard PCI procedure + pacing post conditioning
Standard PCI procedure
Outcomes
Primary Outcome Measures
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00409604
Brief Title
PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
Official Title
Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Guidant Corporation
4. Oversight
5. Study Description
Brief Summary
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction
Detailed Description
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Standard PCI procedure + pacing post conditioning
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard PCI procedure
Intervention Type
Device
Intervention Name(s)
Temporary RV VVI pacing
Intervention Description
temporary pacing at the onset of revascularisation
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOhannes Waltenberger, Prof.Dr.
Organizational Affiliation
University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Maastricht (azM)
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
24925330
Citation
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.
Results Reference
derived
Learn more about this trial
PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
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