PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
Phase 2
Completed
- Conditions
- Acute Myocardial Infarction
- Interventions
- Device: Temporary RV VVI pacing
- Registration Number
- NCT00409604
- Lead Sponsor
- Guidant Corporation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Temporary RV VVI pacing Standard PCI procedure + pacing post conditioning
- Primary Outcome Measures
Name Time Method Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months 4 & 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital of Maastricht (azM)
🇳🇱Maastricht, Netherlands