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

This study is ongoing, but not recruiting participants.

First Received: December 8, 2006 Last Updated: December 5, 2008 History of Changes

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00409604

Purpose

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

Condition	Intervention	Phase
Acute Myocardial Infarction	Device: Temporary RV VVI pacing	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	December 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Standard PCI procedure + pacing post conditioning	Device: Temporary RV VVI pacing temporary pacing at the onset of revascularisation
2: No Intervention Standard PCI procedure

Detailed Description:

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

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409604

Locations

Netherlands
University Hospital of Maastricht (azM)
Maastricht, Netherlands

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

JOhannes Waltenberger, Prof.Dr.

University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands

More Information

No publications provided

Responsible Party:	Guidant Europe ( Racho Strauven )
Study ID Numbers:	CS1017-001
Study First Received:	December 8, 2006
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00409604 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 01, 2009