NCT00409604CompletedPhase 2
Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Guidant Corporation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Standard PCI procedure + pacing post conditioning
Intervention: Temporary RV VVI pacing (Device)
2
No Intervention
Standard PCI procedure
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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