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

Acute Myocardial Infarction Clinical Trial

Official title:

Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409604
• Other study ID #: CS1017-001
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2006
• Last updated: August 30, 2010
• Start date: December 2006
• Est. completion date: August 2009

Study information

• Verified date: August 2010
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Myocardial Infarction

Intervention

Device:
• Temporary RV VVI pacing
temporary pacing at the onset of revascularisation

Locations

Country	Name	City	State
Netherlands	University Hospital of Maastricht (azM)	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months		4 & 12 months	No