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

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

Completed

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Maastricht (azM)

Maastricht, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary RV VVI pacing

Device

temporary pacing at the onset of revascularisation

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

Sponsors and collaborators

Lead sponsor

Guidant Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Dec 11, 2006
Registry last updated: Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed