Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-28 @ 10:18 AM
Study NCT ID:
NCT06103357
Status:
UNKNOWN
Last Update Posted:
2024-03-05
First Post:
2023-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Biomarkers in Subjects With Coronary Syndrome (PLAQUE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'miRNome analysis', 'timeFrame': 'baseline', 'description': 'The Next Generation Sequencing (NGS) techniques will be used to identify miRNome picture as potential biomarkers for acute and chronic coronary syndrome.'}], 'secondaryOutcomes': [{'measure': 'Identification of biomarkers of inflammation', 'timeFrame': 'baseline', 'description': 'Interleukin-6 and soluble ST2 levels will be assessed in plasma samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome', 'Chronic Coronary Syndrome', 'microRNAs', 'soluble ST2', 'interleukin-6'], 'conditions': ['Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '40512691', 'type': 'DERIVED', 'citation': 'Protic O, Bonfigli AR, Olivieri F, Lamedica AM, Gabrielli G, Antonicelli R. miRNome profile in blood samples upstream and downstream of the coronary lesion and arterial aortic root before and after angioplasty in subjects with chronic and acute coronary syndrome: A pilot observational study protocol (Plaque study). PLoS One. 2025 Jun 13;20(6):e0324467. doi: 10.1371/journal.pone.0324467. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The study will to test the levels of innovative biomarkers, such as miRNAs, in the blood of subjects underwent to angioplasty procedure according to standard clinical practice.', 'detailedDescription': 'Twenty patients with acute coronary syndrome from non-ST-segment elevation myocardial infarction or with chronic coronary syndrome with clinical indication and favorable anatomy for coronary angioplasty will be enrolled. The angioplasty procedure will be performed according to standard clinical practice. Before and after angioplasty, blood samples will be taken upstream and downstream of the coronary lesion, arterial sampling will be performed at the level of the aortic root, and peripheral venous blood will be collected. MicroRNA expression will be analyzed in serum by next-generation sequencing (miRNome). Quantitative analysis of pro- and anti-inflammatory molecules such as IL-6 and the soluble form of IL-33 receptor (sST2) will be performed on various blood samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by Acute Coronary Syndrome (ACS) and Chronic Coronary Syndrome (CCS) with clinical indications for coronary angiography, demonstrating the presence of significant coronary artery disease.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication for the PCI procedure according to the latest ESC (European Society of Cardiology) Guidelines\n* Coronary stenosis treated with angioplasty must be located in the proximal segments of the three main vessels: IVA, CX and CD\n* The vessels must have a diameter of their mid-distal section ≥ 3 mm\n* Patients with NSTEMI ACS and clinical indication with favorable anatomy for coronary angioplasty, also called percutaneous coronary intervention (PCI), (for the ACS group)\n* Patients with clinically incipient SCC with stable angina (or significant anginal equivalents) and clinical indication with favorable anatomy for PCI (for the SCC group)\n\nExclusion Criteria:\n\n* Contraindications to anticoagulant/antiplatelet therapy\n* Extensive calcifications and/or tortuosity of the major epicardial segments\n* Evidence of thrombotic occupation\n* Patients with hemodynamic instability\n* Patients with EF (ejection fraction) \\< 35%\n* Patients with severe chronic renal failure (e-GFR \\< 30 mL/min)'}, 'identificationModule': {'nctId': 'NCT06103357', 'acronym': 'PLAQUE', 'briefTitle': 'Identification of Biomarkers in Subjects With Coronary Syndrome (PLAQUE Study)', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Nazionale di Ricovero e Cura per Anziani'}, 'officialTitle': 'Identification of Innovative Circulating and Cellular Biomarkers in Subjects With Acute and Chronic Coronary Syndrome (PLAQUE Study)', 'orgStudyIdInfo': {'id': 'INRCA_009_2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subjects with clinical indication for coronary angioplasty', 'description': 'Twenty subjects with acute or chronic coronary syndrome that will be underwent to angioplasty procedure according to standard clinical practice.', 'interventionNames': ['Other: blood sample collection']}], 'interventions': [{'name': 'blood sample collection', 'type': 'OTHER', 'description': 'Before and after angioplasty, blood samples upstream and downstream of the coronary lesion will be taken, arterial sampling at the aortic root level will be performed, and peripheral venous blood will be collected.', 'armGroupLabels': ['subjects with clinical indication for coronary angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Olga Protic, PhD', 'role': 'CONTACT', 'email': 'o.protic@inrca.it'}, {'name': 'Gabriele Gabrielli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], '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': 'Roberto Antonicelli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS INRCA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Nazionale di Ricovero e Cura per Anziani', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}