Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-03-08 @ 1:54 AM
Study NCT ID:
NCT03298659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion \\>50% and iFR ≤0.89; or (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1146}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-26', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite end point of Major Adverse Cardiac Events', 'timeFrame': '3 years', 'description': 'All-cause death, recurrent myocardial infarction and hospitalization for heart failure'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'All cause mortality at 6 and 12 months, 3 and 5 years'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Cardiovascular mortality at 6 and 12 months, 3 and 5 years'}, {'measure': 'Myocardial infarction', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Myocardial infarction at 6 and 12 months, 3 and 5 years'}, {'measure': 'Cerebral events', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Stroke and transient ischemic attack'}, {'measure': 'Major bleeding', 'timeFrame': '6 months', 'description': 'Haemorrhagic complications'}, {'measure': 'Unstable angina', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years'}, {'measure': 'Coronary angiography', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Coronary angiography at 6 and 12 months, 3 and 5 years'}, {'measure': 'Revascularization', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Any revascularization at 6 and 12 months, 3 and 5 years'}, {'measure': 'Target lesion failure', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Failure and/or revascularization by percutaneous or surgical methods of the target lesion'}, {'measure': 'Stent thrombosis', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Stent thrombosis at 6 and 12 months, 3 and 5 years'}, {'measure': 'Cost effectiveness analysis', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Costs related to complete, iFR-guided revascularization versus CMR-guided treatment, including cost utility analysisfrom a societal perspective with the costs per prevented cardiac eventand the costs per QALY as the respective primary health economic outcomes (using a quality of life questionnaire and a health care resource use questionnaire)'}, {'measure': 'Quality of life', 'timeFrame': '6 and 12 months, 3 and 5 years', 'description': 'Quality of life questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction', 'Multi Vessel Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '41159879', 'type': 'DERIVED', 'citation': "Nijveldt R, Maeng M, Beijnink CWH, Piek JJ, Al-Lamee RK, Raposo L, Baptista SB, Escaned J, Davies J, Klem I, Yosofi B, van Geuns RM, Frederiksen CA, Jakobsen L, El Barzouhi A, van der Heijden DJ, Ilhan M, Rasoul S, Brinckman S, Saraber C, Jones DA, Petersen SE, Podlesnikar T, Bunc M, Beijk MAM, Piers LH, van Rees JB, Seligman H, Cole G, Iglesias JF, Degrauwe S, van 't Hof AWJ, Lipsic E, Pundziute-do Prado G, Chattranukulchai P, Rodriguez-Palomares JF, Rigger J, Meuwissen M, Kleijn L, Pereira B, Monti L, van der Schaaf RJ, Sanchis J, Belli G, Tijssen JGP, Thim T, van Royen N; iMODERN Investigators. Immediate or Deferred Nonculprit-Lesion PCI in Myocardial Infarction. N Engl J Med. 2025 Oct 28. doi: 10.1056/NEJMoa2512918. Online ahead of print."}, {'pmid': '35811565', 'type': 'DERIVED', 'citation': 'Ong P, Martinez Pereyra V, Sechtem U, Bekeredjian R. Management of patients with ST-segment myocardial infarction and multivessel disease: what are the options in 2022? Coron Artery Dis. 2022 Sep 1;33(6):485-489. doi: 10.1097/MCA.0000000000001157. Epub 2022 Jul 11.'}, {'pmid': '33452200', 'type': 'DERIVED', 'citation': 'Beijnink CWH, Thim T, van der Heijden DJ, Klem I, Al-Lamee R, Vos JL, Koop Y, Dijkgraaf MGW, Beijk MAM, Kim RJ, Davies J, Raposo L, Baptista SB, Escaned J, Piek JJ, Maeng M, van Royen N, Nijveldt R. Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial. BMJ Open. 2021 Jan 15;11(1):e044035. doi: 10.1136/bmjopen-2020-044035.'}]}, 'descriptionModule': {'briefSummary': 'In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel disease with an increased cardiovascular morbidity and mortality. Although it is not recommended to revascularize noninfarct lesions during the acute intervention, recent investigations suggest the opposite and show improved outcome after direct revascularization of noninfarct lesions. It is undesirable to risk procedure-related complications by treating noninfarct lesions without impaired flow. It is currently unknown whether pressure guided revascularization of noninfarct lesions in the acute phase improves outcome compared to the current guidelines.\n\nThe iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel lesions.', 'detailedDescription': 'Study design:\n\nThe study is a prospective, randomized controlled, multicentre study.\n\nStudy population:\n\nThe research population will be recruited from the general patient population presenting with an acute STEMI. Patients treated with successful primary PCI and one or more additional significant coronary lesions in another coronary artery will be enrolled in the study. A total of 1,146 consecutive patients will be included.\n\nIntervention:\n\nThe patients will be randomized 1:1, to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion \\>50% and iFR ≤0.89; (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.\n\nMain study parameters/endpoints:\n\nThe primary end point consists of a combined outcome, including all-cause death, recurrent MI and hospitalization for heart failure at 3 years follow-up.\n\nDuration:\n\nAnticipated recruitment is 2 years. Follow-up will be performed at 6 months, 12 months, 3 years and 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical presentation of STEMI and successful primary PCI within 12 hours from onset of symptoms.\n* One or more other, noninfarct coronary artery lesions of \\>50% stenosis and feasible to be revascularized (i.e. minimal diameter 2mm).\n\nExclusion Criteria:\n\n* History of myocardial infarction.\n* Hemodynamic instability, respiratory failure, Kilips class ≥III.\n* Known GFR\\<30 ml/min.\n* Known contra-indications for stress CMR (e.g.: severe claustrophobia, metal implants, severe renal failure, severe astma).\n* Refusal or inability to provide informed consent.\n* Life expectancy due to noncardiovascular co-morbidity of less than 12 months.\n* Chronic total occlusion.\n* Left main stem stenosis (\\>50%).\n* Residual noninfarct lesion in infarct coronary artery.\n* Complex (e.g. bifurcation) noninfarct target lesions.'}, 'identificationModule': {'nctId': 'NCT03298659', 'acronym': 'iMODERN', 'briefTitle': 'iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)', 'orgStudyIdInfo': {'id': 'NL60107.029.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active iFR-guided revascularization', 'description': 'Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment', 'interventionNames': ['Diagnostic Test: iFR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deferred CMR-guided revascularization', 'description': 'Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging', 'interventionNames': ['Diagnostic Test: CMR']}], 'interventions': [{'name': 'iFR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Treatment guided by instantaneous wave-free ratio', 'armGroupLabels': ['Active iFR-guided revascularization']}, {'name': 'CMR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Treatment guided by stress perfusion CMR', 'armGroupLabels': ['Deferred CMR-guided revascularization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Volcano Europe BVBA/SPRL', 'class': 'UNKNOWN'}, {'name': 'Biotronik AG', 'class': 'INDUSTRY'}, {'name': 'Stichting Life Sciences & Health', 'class': 'UNKNOWN'}, {'name': 'Duke Cardiovascular Magnetic Resonance Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}