PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)

Guidant

Status and phase: Completed; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Device: Temporary RV VVI pacing

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409604

CS1017-001

Details and patient eligibility

About

To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Full description

To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

Standard PCI procedure + pacing post conditioning

Treatment:

Device: Temporary RV VVI pacing

2

No Intervention group

Description:

Standard PCI procedure