Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 7:01 PM
Study NCT ID:
NCT01818960
Status:
UNKNOWN
Last Update Posted:
2016-07-29
First Post:
2013-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Revascularization Strategies for STEMI; The CMR Endpoint Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2013-03-23', 'studyFirstSubmitQcDate': '2013-03-23', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'LV function', 'timeFrame': '90 days and one year'}], 'primaryOutcomes': [{'measure': 'Infarct size by CMR', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'MACE rate', 'timeFrame': 'One year', 'description': 'MACE rate at 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stent, Myocardial Infarction, Coronary Intervention'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies \\[same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)\\] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.\n* Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR\\<0.80 for 50-70% stenosis) stenosis in non-IRA.\n* Successful IRA-PCI with \\<10% residual angiographic stenosis and TIMI III flow.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Age ≤ 18 years.\n* Prior coronary artery bypass graft (CABG) surgery.\n* Administration of thrombolytic therapy.\n* Non-IRA stenosis is a chronic total occlusion or located in left main artery.\n* Hemodynamic instability evidenced by BP\\<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.\n* Known renal insufficiency (estimated GFR \\< 50ml/min).\n* Contraindication to CMR.'}, 'identificationModule': {'nctId': 'NCT01818960', 'acronym': 'ASSIST-CMR', 'briefTitle': 'Revascularization Strategies for STEMI; The CMR Endpoint Study', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Revascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study', 'orgStudyIdInfo': {'id': 'AC-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SS-PCI', 'description': 'Same sitting multivessel PCI as an adjunct to primary PCI', 'interventionNames': ['Procedure: SS-PCI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IRA-PCI', 'description': 'IRA only PCI with planned staging for non-IRA lesions', 'interventionNames': ['Procedure: IRA-PCI']}], 'interventions': [{'name': 'IRA-PCI', 'type': 'PROCEDURE', 'description': 'IRA only PCI at the time of Primary PCI', 'armGroupLabels': ['IRA-PCI']}, {'name': 'SS-PCI', 'type': 'PROCEDURE', 'description': 'Same sitting multivessel PCI as an adjunct to primary PCI', 'armGroupLabels': ['SS-PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Shahar Lavi, MD', 'role': 'CONTACT', 'email': 'shahar.lavi@lhsc.on.ca', 'phone': '519-663-3611'}], 'facility': 'London Health Sciences', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mohammed Hussein', 'role': 'CONTACT', 'email': 'husseinmo@smh.ca', 'phone': '4168646060', 'phoneExt': '4014'}, {'name': 'Asim Cheema, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Akshay Bagai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'S4P 0W5', 'city': 'Regina', 'state': 'Saskatchewan', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sheila Kelly, MSc', 'role': 'CONTACT', 'email': 'sheila@skresearch.com', 'phone': '306-522-7275'}, {'name': 'Payam Dehghani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Regina Qu'Appelle Health Region", 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}