PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
NCT ID: NCT00409604
Last Updated: 2010-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2006-12-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Standard PCI procedure + pacing post conditioning
Temporary RV VVI pacing
temporary pacing at the onset of revascularisation
2
Standard PCI procedure
No interventions assigned to this group
Interventions
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Temporary RV VVI pacing
temporary pacing at the onset of revascularisation
Eligibility Criteria
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Inclusion Criteria
* Total occlusion of a coronary artery with reference vessel diameter \>or= 3mm
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Guidant Corporation
INDUSTRY
Responsible Party
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Guidant Europe
Principal Investigators
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JOhannes Waltenberger, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
Locations
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University Hospital of Maastricht (azM)
Maastricht, , Netherlands
Countries
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References
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Waltenberger J, Gelissen M, Bekkers SC, Vainer J, van Ommen V, Eerens F, Ruiters A, Holthuijsen A, Cuesta P, Strauven R, Mokelke E, Gorgels A, Prinzen FW. Clinical pacing post-conditioning during revascularization after AMI. JACC Cardiovasc Imaging. 2014 Jun;7(6):620-6. doi: 10.1016/j.jcmg.2014.01.017.
Other Identifiers
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CS1017-001
Identifier Type: -
Identifier Source: org_study_id