Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT00409604
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2006-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-30', 'studyFirstSubmitDate': '2006-12-08', 'studyFirstSubmitQcDate': '2006-12-08', 'lastUpdatePostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months', 'timeFrame': '4 & 12 months'}]}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '24925330', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction', 'detailedDescription': 'To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms\n* Total occlusion of a coronary artery with reference vessel diameter \\>or= 3mm\n\nExclusion Criteria:\n\n* Thrombolitics\n* Severe bradycardia requiring cardiac pacing\n* Previous PCI or CABG\n* Recent stroke or CV surgery\n* Recent major surgery or trauma\n* Clinical and hemodynamic unstability\n* Implanted CRM device\n* Evidence of previous MI\n* Diabetes using rosiglitazone or other fibrates\n* Permanent AF\n* Mechanical tricuspid valve\n* Pregnancy\n* Exclusion for MRI\n* Incapability of participating in exercise test'}, 'identificationModule': {'nctId': 'NCT00409604', 'briefTitle': 'PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guidant Corporation'}, 'officialTitle': 'Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study', 'orgStudyIdInfo': {'id': 'CS1017-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Standard PCI procedure + pacing post conditioning', 'interventionNames': ['Device: Temporary RV VVI pacing']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Standard PCI procedure'}], 'interventions': [{'name': 'Temporary RV VVI pacing', 'type': 'DEVICE', 'description': 'temporary pacing at the onset of revascularisation', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'University Hospital of Maastricht (azM)', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'JOhannes Waltenberger, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guidant Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Racho Strauven', 'oldOrganization': 'Guidant Europe'}}}}