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

Primary Purpose

Acute Myocardial Infarction

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Temporary RV VVI pacing

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Maastricht (azM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Standard PCI procedure + pacing post conditioning

Standard PCI procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00409604

First Posted

December 8, 2006

Last Updated

August 30, 2010

Sponsor

Guidant Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00409604

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Guidant Corporation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Standard PCI procedure + pacing post conditioning

Arm Title

Arm Type

No Intervention

Arm Description

Standard PCI procedure

Intervention Type

Device

Intervention Name(s)

Temporary RV VVI pacing

Intervention Description

temporary pacing at the onset of revascularisation

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JOhannes Waltenberger, Prof.Dr.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Maastricht (azM)

City

Maastricht

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

24925330

Citation

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.

Results Reference

derived

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

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