Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-03-24 @ 6:54 PM
Study NCT ID:
NCT06902857
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2025-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Predictive Value of High-sensitivity Cardiac Troponin I, N-terminal Pro-B-natriuretic Peptide, and Soluble Suppression of Tumorigenesis-2 for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma samples will be stored at -80°C at the BioGer biobank of IRCCS INRCA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1002}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-29', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-24', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of all-cause mortality', 'timeFrame': 'From date of enrollment up to 36 months', 'description': 'Death from any cause'}], 'secondaryOutcomes': [{'measure': 'Change in high-sensitivity cardiac troponin I levels', 'timeFrame': 'At enrollment and 36 months later', 'description': 'The levels of high-sensitivity cardiac troponin I will be analyzed.'}, {'measure': 'The occurence of cardiovascular events', 'timeFrame': 'From date of enrollment up to 36 months', 'description': 'Non-fatal cardiovascular events'}, {'measure': 'The Incidence of new diabetic complications', 'timeFrame': 'From date of enrollment up to 36 months', 'description': 'The onset of new micro and macrovascular complications of diabetes will be recorded'}, {'measure': 'Change in soluble suppression of tumorigenesis-2 levels', 'timeFrame': 'From date of enrollment up to 36 months', 'description': 'The levels of soluble suppression of tumorigenesis-2 will be analyzed.'}, {'measure': 'Change in N-terminal pro-B-natriuretic peptide levels', 'timeFrame': 'From date of enrollment up to 36 months', 'description': 'The levels of N-terminal pro-B-natriuretic peptide will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'high-sensitivity cardiac troponin I', 'N-terminal pro-B-natriuretic peptide', 'soluble suppression of tumorigenesis-2', 'mortality risk', 'diabetes complications'], 'conditions': ['Type 2 Diabetes', 'Cardiovascular Complication']}, 'descriptionModule': {'briefSummary': 'The Diabetes-CV study is an observational study designed to assess the prognostic value of serum cardiac damage markers high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-natriuretic peptide (NT-proBNP), and soluble suppression of tumorigenesis-2 (sST2) in predicting mortality, major adverse cardiovascular events, and diabetic complications in patients with type 2 diabetes.', 'detailedDescription': 'This single-center, investigator-initiated, prospective observational study aims to evaluate the prognostic value of serum cardiac damage markers such as high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-natriuretic peptide (NT-proBNP) and soluble suppression of tumorigenesis-2 (sST2) in subjects with type 2 diabetes. The study will utilize clinical and laboratory data from patients attending the Diabetology Unit at the IRCCS INRCA Hospital in Ancona (Italy), including both study-specific data and information extracted from routine outpatient medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with type 2 diabetes attending the outpatient services for the routine checkups.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* patients attending the outpatient services\n\nExclusion Criteria:\n\n* type 1 diabetes\n* patients with active cancer or cancer in remission for less than 5 years\n* any medical or other reason that leads the investigator to consider the subject ineligible for the study.'}, 'identificationModule': {'nctId': 'NCT06902857', 'acronym': 'Diabetes-CV', 'briefTitle': 'Study on the Predictive Value of High-sensitivity Cardiac Troponin I, N-terminal Pro-B-natriuretic Peptide, and Soluble Suppression of Tumorigenesis-2 for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV)', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Nazionale di Ricovero e Cura per Anziani'}, 'officialTitle': 'Prospective Observational Study on the Predictive Value of Cardiac Damage Markers High-sensitivity Cardiac Troponin I (Hs-cTnI), N-terminal Pro-B-natriuretic Peptide (NT-proBNP) and Soluble Suppression of Tumorigenesis-2 (sST2) for Mortality and the Development of Cardiovascular Events in Patients With Type 2 Diabetes (Diabetes-CV).', 'orgStudyIdInfo': {'id': 'INRCA_002_2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with diabetes', 'description': 'Patients with type 2 diabetes attending routine check-ups at the Diabetology Unit outpatient clinic.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60127', 'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Adrianapia Maria Lamedica', 'role': 'CONTACT', 'email': 'a.lamedica@inrca.it', 'phone': '0718003854'}], 'facility': 'IRCCS INRCA Hospital', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}], 'centralContacts': [{'name': 'Anna Rita Bonfigli, PhD', 'role': 'CONTACT', 'email': 'a.bonfigli@inrca.it', 'phone': '0718003719'}], 'overallOfficials': [{'name': 'Elena Tortato, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS INRCA, Ancona, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Nazionale di Ricovero e Cura per Anziani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}