Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-06 @ 3:44 AM
Study NCT ID:
NCT01960933
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2013-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause death, myocardial infarction or revascularization', 'timeFrame': '1 year', 'description': 'Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure'}], 'secondaryOutcomes': [{'measure': 'Cardiac death or myocardial infarction', 'timeFrame': '1 year'}, {'measure': 'Hospitalization for acute coronary syndrome or acute heart failure', 'timeFrame': '1 year'}, {'measure': 'Angina status and quality of life', 'timeFrame': '1 year'}, {'measure': 'Infarct size in relation to area at risk as determined by MRI', 'timeFrame': '3 months'}, {'measure': 'Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions', 'timeFrame': '2 years'}, {'measure': 'Wall motion index (WMI) determined by echocardiography', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['STEMI', 'MVD', 'Full revascularization', 'Culprit lesion revascularization only', 'Primary PCI'], 'conditions': ['ST-elevation Myocardial Infarction', 'Multi Vessel Disease']}, 'referencesModule': {'references': [{'pmid': '41238348', 'type': 'DERIVED', 'citation': 'Ozbek BT, Islam U, Marquard JM, Kelbaek H, Kunkel JB, Holmvang L, Tilsted HH, Pedersen F, Koeber L, Hofsten D, Eftekhari A, Raungaard B, Bottker HE, Terkelsen CJ, Christiansen E, Khalek IMA, Jensen LO, Engstrom T, Lonborg JT. Ten-year target lesion failure in patients treated with primary PCI: results from DANAMI-3. Open Heart. 2025 Nov 13;12(2):e003588. doi: 10.1136/openhrt-2025-003588.'}, {'pmid': '40392668', 'type': 'DERIVED', 'citation': 'Marquard JM, Beske RP, Kelbaek H, Holmvang L, Pedersen F, Clemmensen P, De Backer O, Raungaard B, Eftekhari A, Islam U, Kober L, Tilsted HH, Glinge C, Jabbari R, Scheike T, Hofsten DE, Lonborg JT, Engstrom T. 10-Year Outcome of Complete or Infarct Artery-Only Revascularization in STEMI With Multivessel Disease: The DANAMI-3-PRIMULTI Study. J Am Coll Cardiol. 2025 Jul 15;86(2):119-129. doi: 10.1016/j.jacc.2025.05.013. Epub 2025 May 20.'}, {'pmid': '35990971', 'type': 'DERIVED', 'citation': 'Mazhar J, Ekstrom K, Kozor R, Grieve SM, Nepper-Christensen L, Ahtarovski KA, Kelbaek H, Hofsten DE, Kober L, Vejlstrup N, Vernon ST, Engstrom T, Lonborg J, Figtree GA. Cardiovascular magnetic resonance characteristics and clinical outcomes of patients with ST-elevation myocardial infarction and no standard modifiable risk factors-A DANAMI-3 substudy. Front Cardiovasc Med. 2022 Aug 3;9:945815. doi: 10.3389/fcvm.2022.945815. eCollection 2022.'}, {'pmid': '33951923', 'type': 'DERIVED', 'citation': 'Ekstrom K, Nielsen JVW, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Ischemia From Nonculprit Stenoses Is Not Associated With Reduced Culprit Infarct Size in Patients with ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2021 May;14(5):e012290. doi: 10.1161/CIRCIMAGING.120.012290. Epub 2021 May 5.'}, {'pmid': '31005537', 'type': 'DERIVED', 'citation': 'Ekstrom K, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Helqvist S, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Impact of Multiple Myocardial Scars Detected by CMR in Patients Following STEMI. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2168-2178. doi: 10.1016/j.jcmg.2019.01.032. Epub 2019 Apr 17.'}, {'pmid': '30823897', 'type': 'DERIVED', 'citation': 'Wang LJ, Han S, Zhang XH, Jin YZ. Fractional flow reserve-guided complete revascularization versus culprit-only revascularization in acute ST-segment elevation myocardial infarction and multi-vessel disease patients: a meta-analysis and systematic review. BMC Cardiovasc Disord. 2019 Mar 1;19(1):49. doi: 10.1186/s12872-019-1022-6.'}, {'pmid': '30354595', 'type': 'DERIVED', 'citation': 'Nepper-Christensen L, Lonborg J, Hofsten DE, Ahtarovski KA, Bang LE, Helqvist S, Kyhl K, Kober L, Kelbaek H, Vejlstrup N, Holmvang L, Engstrom T. Benefit From Reperfusion With Primary Percutaneous Coronary Intervention Beyond 12 Hours of Symptom Duration in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2018 Sep;11(9):e006842. doi: 10.1161/CIRCINTERVENTIONS.118.006842.'}, {'pmid': '30213322', 'type': 'DERIVED', 'citation': 'Kobayashi Y, Lonborg J, Jong A, Nishi T, De Bruyne B, Hofsten DE, Kelbaek H, Layland J, Nam CW, Pijls NHJ, Tonino PAL, Warnoe J, Oldroyd KG, Berry C, Engstrom T, Fearon WF; DANAMI-3-PRIMULTI, FAME, and FAMOUS-NSTEMI Study Investigators. Prognostic Value of the Residual SYNTAX Score After Functionally Complete Revascularization in ACS. J Am Coll Cardiol. 2018 Sep 18;72(12):1321-1329. doi: 10.1016/j.jacc.2018.06.069.'}, {'pmid': '29776961', 'type': 'DERIVED', 'citation': 'Falkentoft AC, Rorth R, Iversen K, Hofsten DE, Kelbaek H, Holmvang L, Frydland M, Schoos MM, Helqvist S, Axelsson A, Clemmensen P, Jorgensen E, Saunamaki K, Tilsted HH, Pedersen F, Torp-Pedersen C, Kofoed KF, Goetze JP, Engstrom T, Kober L. MR-proADM as a Prognostic Marker in Patients With ST-Segment-Elevation Myocardial Infarction-DANAMI-3 (a Danish Study of Optimal Acute Treatment of Patients With STEMI) Substudy. J Am Heart Assoc. 2018 May 18;7(11):e008123. doi: 10.1161/JAHA.117.008123.'}, {'pmid': '28404623', 'type': 'DERIVED', 'citation': 'Lonborg J, Engstrom T, Kelbaek H, Helqvist S, Klovgaard L, Holmvang L, Pedersen F, Jorgensen E, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L, Hofsten DE; DANAMI 3-PRIMULTI Investigators. Fractional Flow Reserve-Guided Complete Revascularization Improves the Prognosis in Patients With ST-Segment-Elevation Myocardial Infarction and Severe Nonculprit Disease: A DANAMI 3-PRIMULTI Substudy (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization). Circ Cardiovasc Interv. 2017 Apr;10(4):e004460. doi: 10.1161/CIRCINTERVENTIONS.116.004460.'}, {'pmid': '26347918', 'type': 'DERIVED', 'citation': 'Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.'}, {'pmid': '25965708', 'type': 'DERIVED', 'citation': 'Hofsten DE, Kelbaek H, Helqvist S, Klovgaard L, Holmvang L, Clemmensen P, Torp-Pedersen C, Tilsted HH, Botker HE, Jensen LO, Kober L, Engstrom T; DANAMI 3 Investigators. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. Am Heart J. 2015 May;169(5):613-21. doi: 10.1016/j.ahj.2015.02.004. Epub 2015 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.', 'detailedDescription': 'STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).\n\nEligible coronary arteries must be \\>2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses \\> 50% can be randomized. All randomized lesions with diameter stenosis \\> 50% and \\< 90% are evaluated by FFR and a FFR value \\< 0.80 is considered significant and treated. Stenoses \\>90% are treated without prior FFR.\n\nFull revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Acute onset of chest pain of \\< 12 hours' duration.\n* ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.\n* Culprit lesion in a major native vessel.\n* MVD (non-culprit vessels with angiographic stenosis \\>50%)\n* Successful primary PCI\n\nExclusion Criteria:\n\n* Pregnancy.\n* Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.\n* Inability to understand information or to provide informed consent.\n* Haemorrhagic diathesis or known coagulopathy.\n* Stent thrombosis\n* Significant left main stem stenosis\n* Cardiogenic shock at admittance"}, 'identificationModule': {'nctId': 'NCT01960933', 'acronym': 'PRIMULTI', 'briefTitle': 'Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'DANAMI-3-PRIMULTI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Culprit lesion revascularization', 'description': 'Only the culprit lesion is treated whereas other study lesions are left un-treated.', 'interventionNames': ['Procedure: Percutaneous coronary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Full revascularization', 'description': 'Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically \\>50% and FFR \\<0.80 are treated in a separate procedure within the index hospitalization. Stenoses \\> 90% are treated without prior FFR.', 'interventionNames': ['Procedure: Percutaneous coronary intervention', 'Procedure: FFR']}], 'interventions': [{'name': 'Percutaneous coronary intervention', 'type': 'PROCEDURE', 'armGroupLabels': ['Culprit lesion revascularization', 'Full revascularization']}, {'name': 'FFR', 'type': 'PROCEDURE', 'armGroupLabels': ['Full revascularization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9100', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Steffen Helqvist, MD, DMSci', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, University of Copenhagen, Denmark'}, {'name': 'Thomas Engstrøm, MD, DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, University of Copenhagen, Denmark'}, {'name': 'Henning Kelbæk, MD. DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, University of Copenhagen, Denmark'}, {'name': 'Lars Køber, MD, Prof., DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, University of Copenhagen, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Senior Consultant, DMSCi', 'investigatorFullName': 'Thomas Engstrom', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}