Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 10:53 AM
Study NCT ID:
NCT06261866
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome
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': 200}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis', 'timeFrame': 'Baseline'}, {'measure': 'Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FFR', 'OCT', 'IVUS', 'CCS'], 'conditions': ['Chronic Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.', 'detailedDescription': 'This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.\n\nThe additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis.\n\nWe hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)\n* Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography\n* FFR and OCT examination of the same lesion\n* The patient is willing to participate in the study and has provided a written informed consent\n\nExclusion Criteria:\n\n* Acute coronary syndrome\n* Proximal left main lesion\n* Ostial right coronary artery lesion\n* Bypass of the assessed vessel\n* Contraindications for adenosine administration\n* Hemodynamic instability\n* Heart insufficiency in New York Heart Association (NYHA) class IV scale\n* Acute renal insufficiency\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06261866', 'acronym': 'MultiInter-CCS', 'briefTitle': 'Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study', 'orgStudyIdInfo': {'id': 'MultiInter-CCS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with chronic coronary syndromes identified with intermediate grade coronary stenosis', 'description': 'Patients chronic coronary syndrome identified with intermediate grade coronary stenosis undergo coronary angiography according to current practice and guidelines recommendations. FFR will be measured, in consistency with the guidelines and recommended clinical practice. In case of FFR \\> 0.8 optimal pharmacotherapy will be prescribed; on the contrary, in case of FFR ≤ 0.8 PCI will be performed. OCT imaging will be performed with commercially available device (Abbott, C7XR Dragonfly TM LightLab Imaging Inc., MA, USA) using the non-occlusive flushing technique.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Mariusz Tomaniak, MD, PhD, Assoc. Prof.', 'role': 'CONTACT', 'email': 'mariusz.tomaniak@wum.edu.pl'}, {'name': 'Piotr Baruś, MD', 'role': 'CONTACT', 'email': 'piotr.barus@wum.edu.pl'}], 'facility': 'Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Mariusz Tomaniak', 'role': 'CONTACT', 'email': 'mariusz.tomaniak@wum.edu.pl'}, {'name': 'Piotr Baruś', 'role': 'CONTACT', 'email': 'piotr.barus@wum.edu.pl'}], 'overallOfficials': [{'name': 'Mariusz Tomaniak, MD, PhD, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FESC', 'investigatorFullName': 'Mariusz Tomaniak', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}