Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 10:44 AM
Study NCT ID:
NCT01045850
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2010-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2010-01-07', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite cardiovascular and hemorrhagic postoperative complications', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Postoperative death', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary stents', 'non cardiac surgery', 'cardiovascular complications', 'hemorrhagic complications', 'antiplatelet agents', 'bare metal stent', 'drug eluting stent', 'surgery'], 'conditions': ['Cardiovascular Complications', 'Hemorrhagic Complications']}, 'referencesModule': {'references': [{'pmid': '24913999', 'type': 'DERIVED', 'citation': 'Albaladejo P, Charbonneau H, Samama CM, Collet JP, Marret E, Piriou V, Genty C, Bosson JL. Bleeding complications in patients with coronary stents during non-cardiac surgery. Thromb Res. 2014 Aug;134(2):268-72. doi: 10.1016/j.thromres.2014.05.015. Epub 2014 May 15.'}, {'pmid': '21791513', 'type': 'DERIVED', 'citation': 'Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d\'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with coronary stents undergoing non cardiac surgery or invasive procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or more\n* patient requiring a non cardiac surgery\n* patient with a coronary stent\n* patient agree for personal health data collection and analysis\n\nExclusion Criteria:\n\n* patient less than 18 years\n* patient unable to understand'}, 'identificationModule': {'nctId': 'NCT01045850', 'acronym': 'RECO', 'briefTitle': 'Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.', 'orgStudyIdInfo': {'id': 'DTCIC-09-29'}, 'secondaryIdInfos': [{'id': 'CFAR', 'type': 'OTHER', 'domain': "Collège Français d'Anesthésie Réanimation"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Albi', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'city': 'Amiens', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Avignon', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Beaumont', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 45.75165, 'lon': 3.08294}}, {'city': 'Berck', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 50.4, 'lon': 1.6}}, {'city': 'Besançon', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Cabestany', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 42.68141, 'lon': 2.9409}}, {'city': 'Castres', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'city': 'Cavaillon', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.83125, 'lon': 5.03586}}, {'city': 'Chalon En Champagne', 'country': 'France', 'facility': 'HOSPITAL'}, {'city': 'Chenôve', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.29323, 'lon': 5.00457}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Cornebarrieu', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'city': 'Dracy-le-Fort', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 46.7975, 'lon': 4.76215}}, {'city': 'Équeurdreville-Hainneville', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 49.64868, 'lon': -1.65306}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Hyères', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'city': 'Istres', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.51345, 'lon': 4.98747}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'La Seyne-sur-Mer', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.10322, 'lon': 5.87816}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lyon', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Manosque', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.82883, 'lon': 5.78688}}, {'city': 'Mantes-la-Jolie', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'city': 'Marseille', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Maubeuge', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 50.27875, 'lon': 3.97267}}, {'city': 'Metz', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Mulhouse', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'city': 'Nancy', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Niort', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 46.32313, 'lon': -0.45877}}, {'city': 'Paris', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Perpignan', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Redon', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.65165, 'lon': -2.08421}}, {'city': 'Rennes', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Romans', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 46.1198, 'lon': 5.02486}}, {'city': 'Rouen', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Denis', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'city': 'Saint-Dizier', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.63773, 'lon': 4.94892}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'St-Malo', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Trélazé', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'city': 'Villeneuve-sur-Lot', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 44.40854, 'lon': 0.70415}}, {'city': 'Voiron', 'country': 'France', 'facility': 'HOSPITAL', 'geoPoint': {'lat': 45.36471, 'lon': 5.5856}}], 'overallOfficials': [{'name': 'Pierre ALBALADEJO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor ALBALADEJO Pierre', 'oldOrganization': 'University Hospital Grenoble'}}}}