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

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

This study is currently recruiting participants.
Verified by Guidant Corporation, December 2006

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

MedlinePlus related topics:

Heart Attack

U.S. FDA Resources

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

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

Estimated Enrollment:	70
Study Start Date:	December 2006
Estimated Study Completion Date:	August 2008

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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

Contacts and Locations

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

Contacts


Contact: Roger Willems		rwillems@guidant.com

Locations


Netherlands
	University Hospital of Maastricht (azM)	Recruiting
	Maastricht, Netherlands
	Contact: Aimée Lousberg, drs
	Principal Investigator: Johannes Waltenberger, Prof.Dr.

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

Study ID Numbers:	CS1017-001
First Received:	December 8, 2006
Last Updated:	December 19, 2006
ClinicalTrials.gov Identifier:	NCT00409604
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:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2008