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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00409604
Enrollment
60
Registered
2006-12-11
Start date
2006-12-31
Completion date
2009-08-31
Last updated
2010-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

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

Interventions

DEVICETemporary RV VVI pacing

temporary pacing at the onset of revascularisation

Sponsors

Guidant Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months4 & 12 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026