Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05336669
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2021-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '2ml sample of full blood from each patient at baseline 4ml sample of plasma from each patient at each timepoint'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2021-09-24', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACT change', 'timeFrame': 'Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT', 'description': 'Activated Clotting Time'}, {'measure': 'GTT-3 change', 'timeFrame': 'Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT', 'description': 'Global Thrombosis Test'}, {'measure': 'VerifyNow change', 'timeFrame': 'Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT', 'description': 'Platelet inhibition P2Y12 test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary angiography', 'activated clotting time', 'platelet inhibition'], 'conditions': ['Chronic Coronary Insufficiency', 'Smoking']}, 'referencesModule': {'references': [{'pmid': '38241058', 'type': 'DERIVED', 'citation': 'Ramotowski B, Lewandowski P, Slomski T, Maciejewski P, Budaj A. Platelet reactivity and activated clotting time predict hemorrhagic site complications in patients with chronic coronary syndromes undergoing percutaneous coronary interventions. Coron Artery Dis. 2024 Jun 1;35(4):292-298. doi: 10.1097/MCA.0000000000001336. Epub 2024 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'The activated clotting time (ACT), global thrombosis test (GTT-3), platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI).', 'detailedDescription': 'The activated clotting time (ACT), global thrombosis test (GTT-3) and platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI) - 20 smoking and 20 non-smoking.The measurements will take place: before coronary angiography (CA), 10 minutes after unfractionated heparin (HNF), 2h after CA, 6h after CA, 30 days after CA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '40 patients, 20 smoking at least 10 cigarettes a day, 20 patients non-smoking (\\<1 cigarette in last 30 days)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled do CA \\>18 years old\n\nExclusion Criteria:\n\n* pregnancy\n* previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours'}, 'identificationModule': {'nctId': 'NCT05336669', 'acronym': 'GlobalACT', 'briefTitle': 'Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Centre of Postgraduate Medical Education'}, 'officialTitle': 'Coagulation Profile in Patients Undergoing Coronary Intervention Measured With Activated Clotting Time, Global Thrombosis Test and Platelet Inhibition VerifyNow P2Y12 Test', 'orgStudyIdInfo': {'id': '69/VII/Budaj/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-smoking', 'description': 'Non-smoking patients undergoing coronary angiography or percutaneous coronary intervention'}, {'label': 'Smoking', 'description': 'Smoking patients undergoing coronary angiography or percutaneous coronary intervention'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bogumił Ramotowski, MD, PhD', 'role': 'CONTACT', 'email': 'bram@onet.pl', 'phone': '+48604355784'}], 'overallOfficials': [{'name': 'Bogumił Ramotowski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre of Postgraduate Medical Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}