Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-03 @ 5:58 AM
Study NCT ID:
NCT04050956
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Cohort of Myocardial Infarction Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2049-03-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'Through the end of initial hospitalization, an average of 5 days', 'description': 'In-hospital mortality'}, {'measure': 'In-hospital outcomes', 'timeFrame': 'Through the end of initial hospitalization, an average of 5 days', 'description': 'To measure the in-hospital major cardiovascular events : recurrence of AMI, myocardial revascularization, stroke'}, {'measure': 'Lipopretein 1 evolution', 'timeFrame': '9 months after the end of initial hospitalization', 'description': 'To evaluate plasma concentrations of Lpa and its dynamic pattern during hospital index and 3-9 months following hospitalization.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular outcomes during follow-up', 'timeFrame': 'Up to 20 years', 'description': 'All cause death and Cardiovascular events including non fatal Myocardial Infarction, non fatal stroke, revascularization, hospitalization for other cardiovascular causes including Bleeding leading to hospitalization'}, {'measure': 'Non cardiovascular outcomes during follow-up', 'timeFrame': 'Up to 20 years', 'description': 'All cause death and Non-cardiovascular events leading to to hospitalizations'}, {'measure': 'Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management', 'timeFrame': 'Up to 20 years', 'description': "All cause death and cardiovascular events including non fatal MI, non fatal stroke, revascularization, hospitalization for other cardiovascular causes including Bleeding leading to hospitalization according to patient's management"}, {'measure': 'Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management', 'timeFrame': 'Up to 20 years', 'description': "All cause death and Non-cardiovascular events leading to to hospitalizations according to patient's management"}, {'measure': 'Oral comorbidities', 'timeFrame': 'Up to 20 years', 'description': 'Prevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes'}, {'measure': 'Sleep disordered breathing comorbidities', 'timeFrame': 'Up to 20 years', 'description': 'To assess the prevalence of sleep disordered breathing comorbidities and the relationship with early, mid, and long-term prognosis and outcomes'}, {'measure': 'Evaluate the path of care combined with patient care practices following an acute myocardial infarction', 'timeFrame': 'Up to 20 years', 'description': 'Evaluate the path of care and patient care practices following an acute myocardial infarction : Reimbursed or prescribed treatments, combined with number of visits, biological and tests performed'}, {'measure': 'Evaluate the relevance of European Society of Cardiology (ESC), American Heart Association/American College of Cardiology (AHA / ACC) guidelines regarding management of AMI patients', 'timeFrame': 'Up to 20 years', 'description': 'Evaluate the relevance of ESC, AHA/ACC guidelines regarding management of AMI patients'}, {'measure': 'Cost-utility: incremental (or decremental) cost-utility ratio during follow-up', 'timeFrame': 'Up to 20 years', 'description': 'Medical care costs for the index hospitalization and during follow-up period are assessed using a combination of resource-based and event-based methods. In-hospital resource utilization are based on diagnosis and procedural codes and length of stay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myocardial Infarction', 'Registry', 'Outcomes', 'Medico-economic evaluation', 'Comorbidities'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '12127921', 'type': 'BACKGROUND', 'citation': 'Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201. doi: 10.1053/euhj.2002.3193.'}, {'pmid': '15531279', 'type': 'BACKGROUND', 'citation': 'Pedersen TR, Kjekshus J, Berg K, Haghfelt T, Faergeman O, Faergeman G, Pyorala K, Miettinen T, Wilhelmsen L, Olsson AG, Wedel H; Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994. Atheroscler Suppl. 2004 Oct;5(3):81-7. doi: 10.1016/j.atherosclerosissup.2004.08.027. No abstract available.'}, {'pmid': '8801446', 'type': 'BACKGROUND', 'citation': 'Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996 Oct 3;335(14):1001-9. doi: 10.1056/NEJM199610033351401.'}, {'pmid': '12114036', 'type': 'BACKGROUND', 'citation': 'Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. doi: 10.1016/S0140-6736(02)09327-3.'}, {'pmid': '8204123', 'type': 'BACKGROUND', 'citation': 'GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001.'}, {'pmid': '12930925', 'type': 'BACKGROUND', 'citation': 'Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abildgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lomholt P, Husted SE, Vigholt E, Kjaergard HK, Mortensen LS; DANAMI-2 Investigators. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003 Aug 21;349(8):733-42. doi: 10.1056/NEJMoa025142.'}, {'pmid': '12517460', 'type': 'BACKGROUND', 'citation': 'Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.'}, {'pmid': '10338456', 'type': 'BACKGROUND', 'citation': 'Danchin N, Vaur L, Genes N, Etienne S, Angioi M, Ferrieres J, Cambou JP. Treatment of acute myocardial infarction by primary coronary angioplasty or intravenous thrombolysis in the "real world": one-year results from a nationwide French survey. Circulation. 1999 May 25;99(20):2639-44. doi: 10.1161/01.cir.99.20.2639.'}, {'pmid': '9385882', 'type': 'BACKGROUND', 'citation': 'Danchin N, Vaur L, Genes N, Renault M, Ferrieres J, Etienne S, Cambou JP. Management of acute myocardial infarction in intensive care units in 1995: a nationwide French survey of practice and early hospital results. J Am Coll Cardiol. 1997 Dec;30(7):1598-605. doi: 10.1016/s0735-1097(97)00371-9.'}, {'pmid': '15547013', 'type': 'BACKGROUND', 'citation': 'Hanania G, Cambou JP, Gueret P, Vaur L, Blanchard D, Lablanche JM, Boutalbi Y, Humbert R, Clerson P, Genes N, Danchin N; USIC 2000 Investigators. Management and in-hospital outcome of patients with acute myocardial infarction admitted to intensive care units at the turn of the century: results from the French nationwide USIC 2000 registry. Heart. 2004 Dec;90(12):1404-10. doi: 10.1136/hrt.2003.025460.'}, {'pmid': '15451803', 'type': 'BACKGROUND', 'citation': 'Danchin N, Blanchard D, Steg PG, Sauval P, Hanania G, Goldstein P, Cambou JP, Gueret P, Vaur L, Boutalbi Y, Genes N, Lablanche JM; USIC 2000 Investigators. Impact of prehospital thrombolysis for acute myocardial infarction on 1-year outcome: results from the French Nationwide USIC 2000 Registry. Circulation. 2004 Oct 5;110(14):1909-15. doi: 10.1161/01.CIR.0000143144.82338.36. Epub 2004 Sep 27.'}, {'pmid': '15695134', 'type': 'BACKGROUND', 'citation': 'Ferrieres J, Cambou JP, Gueret P, Boutalbi Y, Lablanche JM, Hanania G, Genes N, Cantet C, Danchin N. Effect of early initiation of statins on survival in patients with acute myocardial infarction (the USIC 2000 Registry). Am J Cardiol. 2005 Feb 15;95(4):486-9. doi: 10.1016/j.amjcard.2004.10.016.'}, {'pmid': '11499741', 'type': 'BACKGROUND', 'citation': 'Heidenreich PA, Alloggiamento T, Melsop K, McDonald KM, Go AS, Hlatky MA. The prognostic value of troponin in patients with non-ST elevation acute coronary syndromes: a meta-analysis. J Am Coll Cardiol. 2001 Aug;38(2):478-85. doi: 10.1016/s0735-1097(01)01388-2.'}, {'pmid': '17893635', 'type': 'BACKGROUND', 'citation': 'Cambou JP, Simon T, Mulak G, Bataille V, Danchin N. The French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction (FAST-MI): study design and baseline characteristics. Arch Mal Coeur Vaiss. 2007 Jun-Jul;100(6-7):524-34.'}, {'pmid': '22523054', 'type': 'BACKGROUND', 'citation': 'Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrieres J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.'}, {'pmid': '18591434', 'type': 'BACKGROUND', 'citation': 'Danchin N, Coste P, Ferrieres J, Steg PG, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Gueret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou JP, Simon T; FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation. 2008 Jul 15;118(3):268-76. doi: 10.1161/CIRCULATIONAHA.107.762765. Epub 2008 Jun 30.'}, {'pmid': '24657993', 'type': 'BACKGROUND', 'citation': 'Danchin N, Puymirat E, Steg PG, Goldstein P, Schiele F, Belle L, Cottin Y, Fajadet J, Khalife K, Coste P, Ferrieres J, Simon T; FAST-MI 2005 Investigators. Five-year survival in patients with ST-segment-elevation myocardial infarction according to modalities of reperfusion therapy: the French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Cohort. Circulation. 2014 Apr 22;129(16):1629-36. doi: 10.1161/CIRCULATIONAHA.113.005874. Epub 2014 Mar 21.'}, {'pmid': '19004441', 'type': 'BACKGROUND', 'citation': 'Ferrieres J, Bataille V, Leclercq F, Geslin P, Ruidavets JB, Grollier G, Bernard P, Cambou JP, Simon T, Danchin N. Patterns of statin prescription in acute myocardial infarction: the French registry of Acute ST-elevation or non-ST-elevation Myocardial Infarction (FAST-MI). Atherosclerosis. 2009 Jun;204(2):491-6. doi: 10.1016/j.atherosclerosis.2008.09.031. Epub 2008 Oct 8.'}, {'pmid': '19106083', 'type': 'BACKGROUND', 'citation': 'Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.'}, {'pmid': '22928184', 'type': 'BACKGROUND', 'citation': 'Puymirat E, Simon T, Steg PG, Schiele F, Gueret P, Blanchard D, Khalife K, Goldstein P, Cattan S, Vaur L, Cambou JP, Ferrieres J, Danchin N; USIK USIC 2000 Investigators; FAST MI Investigators. Association of changes in clinical characteristics and management with improvement in survival among patients with ST-elevation myocardial infarction. JAMA. 2012 Sep 12;308(10):998-1006. doi: 10.1001/2012.jama.11348.'}, {'pmid': '25499393', 'type': 'BACKGROUND', 'citation': 'Puymirat E, Schiele F, Steg PG, Blanchard D, Isorni MA, Silvain J, Goldstein P, Gueret P, Mulak G, Berard L, Bataille V, Cattan S, Ferrieres J, Simon T, Danchin N; FAST-MI investigators. Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: insights from the French FAST-MI program over 15 years. Int J Cardiol. 2014 Nov 15;177(1):281-6. doi: 10.1016/j.ijcard.2014.09.023. Epub 2014 Sep 28.'}, {'pmid': '22995875', 'type': 'BACKGROUND', 'citation': 'Puymirat E, Taldir G, Aissaoui N, Lemesle G, Lorgis L, Cuisset T, Bourlard P, Maillier B, Ducrocq G, Ferrieres J, Simon T, Danchin N. Use of invasive strategy in non-ST-segment elevation myocardial infarction is a major determinant of improved long-term survival: FAST-MI (French Registry of Acute Coronary Syndrome). JACC Cardiovasc Interv. 2012 Sep;5(9):893-902. doi: 10.1016/j.jcin.2012.05.008.'}, {'pmid': '15249356', 'type': 'BACKGROUND', 'citation': 'Franklin K, Goldberg RJ, Spencer F, Klein W, Budaj A, Brieger D, Marre M, Steg PG, Gowda N, Gore JM; GRACE Investigators. Implications of diabetes in patients with acute coronary syndromes. The Global Registry of Acute Coronary Events. Arch Intern Med. 2004 Jul 12;164(13):1457-63. doi: 10.1001/archinte.164.13.1457.'}, {'pmid': '12067934', 'type': 'BACKGROUND', 'citation': 'Steg PG, Iung B, Feldman LJ, Cokkinos D, Deckers J, Fox KA, Keil U, Maggioni AP. Impact of availability and use of coronary interventions on the prescription of aspirin and lipid lowering treatment after acute coronary syndromes. Heart. 2002 Jul;88(1):20-4. doi: 10.1136/heart.88.1.20.'}, {'pmid': '12433885', 'type': 'BACKGROUND', 'citation': 'Amar J, Chamontin B, Ferrieres J, Danchin N, Grenier O, Cantet C, Cambou JP. Hypertension control at hospital discharge after acute coronary event: influence on cardiovascular prognosis--the PREVENIR study. Heart. 2002 Dec;88(6):587-91. doi: 10.1136/heart.88.6.587.'}, {'pmid': '12117845', 'type': 'BACKGROUND', 'citation': 'Danchin N, Grenier O, Ferrieres J, Cantet C, Cambou JP. Use of secondary preventive drugs in patients with acute coronary syndromes treated medically or with coronary angioplasty: results from the nationwide French PREVENIR survey. Heart. 2002 Aug;88(2):159-62. doi: 10.1136/heart.88.2.159.'}, {'pmid': '14984919', 'type': 'BACKGROUND', 'citation': "Zeller M, Cottin Y, Brindisi MC, Dentan G, Laurent Y, Janin-Manificat L, L'Huillier I, Beer JC, Touzery C, Makki H, Verges B, Wolf JE; RICO survey working group. Impaired fasting glucose and cardiogenic shock in patients with acute myocardial infarction. Eur Heart J. 2004 Feb;25(4):308-12. doi: 10.1016/j.ehj.2003.12.014."}, {'pmid': '9403607', 'type': 'BACKGROUND', 'citation': 'Chambless L, Keil U, Dobson A, Mahonen M, Kuulasmaa K, Rajakangas AM, Lowel H, Tunstall-Pedoe H. Population versus clinical view of case fatality from acute coronary heart disease: results from the WHO MONICA Project 1985-1990. Multinational MONItoring of Trends and Determinants in CArdiovascular Disease. Circulation. 1997 Dec 2;96(11):3849-59. doi: 10.1161/01.cir.96.11.3849.'}, {'pmid': '9152652', 'type': 'BACKGROUND', 'citation': 'Marques-Vidal P, Ferrieres J, Metzger MH, Cambou JP, Filipiak B, Lowel H, Keil U. Trends in coronary heart disease morbidity and mortality and acute coronary care and case fatality from 1985-1989 in southern Germany and south-western France. Eur Heart J. 1997 May;18(5):816-21. doi: 10.1093/oxfordjournals.eurheartj.a015347.'}, {'pmid': '32950075', 'type': 'RESULT', 'citation': 'Mesnier J, Cottin Y, Coste P, Ferrari E, Schiele F, Lemesle G, Thuaire C, Angoulvant D, Cayla G, Bouleti C, Gallet de Saint Aurin R, Goube P, Lhermusier T, Dillinger JG, Paganelli F, Saib A, Prunier F, Vanzetto G, Dubreuil O, Puymirat E, Boccara F, Eltchaninoff H, Cachanado M, Rousseau A, Drouet E, Steg PG, Simon T, Danchin N. Hospital admissions for acute myocardial infarction before and after lockdown according to regional prevalence of COVID-19 and patient profile in France: a registry study. Lancet Public Health. 2020 Oct;5(10):e536-e542. doi: 10.1016/S2468-2667(20)30188-2. Epub 2020 Sep 18.'}, {'pmid': '38821761', 'type': 'DERIVED', 'citation': 'Gautier A, Danchin N, Ducrocq G, Rousseau A, Cottin Y, Cayla G, Prunier F, Durand-Zaleski I, Ravaud P, Angoulvant D, Coste P, Lemesle G, Bouleti C, Popovic B, Ferrari E, Silvain J, Dubreuil O, Lhermusier T, Goube P, Schiele F, Vanzetto G, Aboyans V, Gallet R, Eltchaninoff H, Thuaire C, Dillinger JG, Paganelli F, Gourmelen J, Steg PG, Simon T; FRENCHIE investigators. Rationale and design of the FRENch CoHort of myocardial Infarction Evaluation (FRENCHIE) study. Arch Cardiovasc Dis. 2024 Jun-Jul;117(6-7):417-426. doi: 10.1016/j.acvd.2024.04.004. Epub 2024 May 22.'}]}, 'descriptionModule': {'briefSummary': 'Over the last two decades, considerable progress has been made in the management of Acute Myocardial Infarction (AMI), both in the acute phase and in monitoring beyond the hospital phase. Nevertheless, the evolution of care practices and their impact on the mid- and long-term prognosis of patients admitted to the intensive care unit for acute myocardial infarction remain relatively little studied exhaustively.\n\nThe aim of this study is to assess the profile of AMI patients, their management and follow-up in order to evaluate the relationship between these factors and outcomes.', 'detailedDescription': 'The FRENCHIE registry is a French multicenter prospective observational study. All the eligible consecutive patients admitted within 48 hours after symptom onset in a cardiac ICU for an acute myocardial infarction.\n\nThis hospital registry will be linked to the national databases, in order to collect follow-up clinical outcomes and health care consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive eligible (cf eligibility criteria) patients admitted in one of the Intensive Coronary Units participating to the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myocardial infarction (MI) within 48h of symptom onset, characterized by the typical increased or fall of troponin (or CPKMB) associated with at least one of the following elements :\n* Symptoms compatible with myocardial ischemia\n* Appearance of pathological Q waves\n* ST- T changes compatible with myocardial ischemia (ST segment elevation or depression, T-wave inversion)\n* Written consent.\n* Covered by French medical insurance ("Sécurité Sociale")\n\nExclusion Criteria:\n\n* Iatrogenic MI defined as MI occurring within 48h of a therapeutic procedure\n* AMI diagnosis invalidated in favor of another diagnosis'}, 'identificationModule': {'nctId': 'NCT04050956', 'acronym': 'FRENCHIE', 'briefTitle': 'French Cohort of Myocardial Infarction Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'French Cohort of Myocardial Infarction Evaluation', 'orgStudyIdInfo': {'id': 'NI17011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myocardial infarction', 'description': 'As it is an observational study, no intervention is planned. However, nested clinical interventional trials are planned for which a specific registration will be done'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe gabriel STEG, PU-PH', 'role': 'CONTACT', 'email': 'gabriel.steg@aphp.fr', 'phone': '00 33 01 40 25 89 69'}, {'name': 'Nicolas DANCHIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Bichat, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Tabassome SIMON', 'role': 'CONTACT', 'email': 'tabassome.simon@aphp.fr', 'phone': '01 40 01 13 93'}, {'name': 'Philippe Gabriel STEG', 'role': 'CONTACT', 'email': 'gabriel.steg@aphp.fr', 'phone': '01 40 25 80 80', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Philippe Gabriel STEG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}