PROTECT : Pacing to Protect Heart for Damage From Blocked... | NCT00409604

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

NCT00409604

Sponsor

Guidant Corporation

Status

Completed

Last Update Posted

Aug 31, 2010Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Acute Myocardial Infarction

Interventions

Temporary RV VVI pacing

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Dec 8, 2006

First Submission Date that Met QC Criteria

Dec 8, 2006

First Posted Date

Dec 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2010

Last Update Posted Date

Aug 31, 2010Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Standard PCI procedure + pacing post conditioning	Device: Temporary RV VVI pacing
2	No Intervention	Standard PCI procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Temporary RV VVI pacing	Device	temporary pacing at the onset of revascularisation	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months		4 & 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JOhannes Waltenberger, Prof.Dr.	University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Maastricht (azM)		Maastricht			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24925330	Derived	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.