Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-06 @ 2:25 AM
Study NCT ID:
NCT05711693
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2023-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000082882', 'term': 'Bicuspid Aortic Valve Disease'}, {'id': 'D008382', 'term': 'Marfan Syndrome'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001794', 'term': 'Blood Pressure'}, {'id': 'D006339', 'term': 'Heart Rate'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'MRI doctors will be blinded concerning LDV PWV values. Doctors performing LDV will not have access to MRI reports. Data will be consolidated and database frozen before reconciling MRI and LDV data'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Comparison of methods'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-25', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart-carotid pulse wave velocity (hcPWV) measured by LDV compared to MRI', 'timeFrame': '1 hour', 'description': 'Values of PWV obtained by LDV and by MRI will be compared.'}], 'secondaryOutcomes': [{'measure': 'Reproducibility of LDV heart-carotid pulse wave velocity (hcPWV)', 'timeFrame': '1 hour', 'description': 'Measures will be duplicated and the average calculated, in case of discrepancy \\> 0.5 m/s, a third measurement is made and the median determined. Two series of measurements will be taken at 5minutes of interval.'}, {'measure': 'Validity of carotid to femoral pulse wave velocity (cfPWV) measured by LDV', 'timeFrame': '1 hour', 'description': 'Values of cfPWV obtained by LDV will be also compared with values obtained by tonometry.'}, {'measure': 'Association of heart-carotid pulse wave velocity (hcPWV) measured by LDV with classical cardiovascular (CV) risk factors and disease', 'timeFrame': '1 hour', 'description': 'The correlation coefficient and linear regression will be calculated.'}, {'measure': 'Acceptability of heart-carotid pulse wave velocity (hcPWV) measured by LDV compared with MRI', 'timeFrame': '1 hour', 'description': 'A questionnaire of acceptability will be completed by the patient after the measurements.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stiffness', 'hypertension', 'ascending aorta'], 'conditions': ['Hypertension', 'Aortic Aneurysm', 'Bicuspid Aortic Valve', 'Marfan Syndrome', 'Aortic Dilatation']}, 'referencesModule': {'references': [{'pmid': '40209757', 'type': 'BACKGROUND', 'citation': 'Beeckman S, Badhwar S, Li Y, Aasmul S, Madhu N, Khettab H, Mousseaux E, Gencer U, Boutouyrie P, Bruno RM, Segers P. Heart-carotid pulse-wave velocity via laser-Doppler vibrometry as a biomarker for arterial stiffening: a feasibility study. Physiol Meas. 2025 Apr 22;46(4). doi: 10.1088/1361-6579/adcb85.'}]}, 'descriptionModule': {'briefSummary': 'Aortic stiffness is an important imaging biomarker of vascular aging. The ascending aorta is the most elastic segment, and it is excluded by reference non-invasive method carotid to femoral pulse wave velocity (PWV). We propose to use laser-doppler vibrometry (LDV) to record superficial vibrations generated by cardiac activity and arterial pulses for measuring heart carotid PWV, a surrogate for ascending aorta.\n\nThe trial aims to demonstrate the equivalence between heart-carotid PWV made by laser-doppler vibrometry (LDV) with the reference MRI measurement (4D-FLOW MRI).\n\nAs secondary objectives, A) we aim to assess the reproducibility of LDV, compared with MRI, B) show that aortic stiffness measured by LDV fulfils international recommendations, C) to study the association between PWV and age or other cardiovascular risk factors, D) assess the acceptability of the measurement. For this, we include 100 consecutive patients, 50 women, 50 men, scheduled for clinically indicated thoracic aorta MRI.', 'detailedDescription': 'Cardiovascular (CV) diseases and their risk factors are the leading causes of morbidity and mortality in the world. They are responsible for more than 17.3 million deaths per year worldwide, accounting for 30% of all causes of death.\n\nThe measurement of arterial stiffness is useful to estimate the global CV risk with more precision than the simple point assessment of the classical cardiovascular risk factors.\n\nCarotid-femoral pulse wave velocity (cfPWV) by tonometry is the reference method. However, it excludes by principle the ascending aorta, which is the most distensible and physiologically the most important segment. The InSiDe project aims to measure heart - carotid pulse wave velocity (hcPWV) from the measurement of skin vibrations on the chest and neck by laser doppler vibrometry (LDV), enclosing principally the ascending aorta. This will allow the measurement and validation of a new biomarker that quantifies the stiffness of the ascending aorta. We have demonstrated a very good agreement of the LDV-based cfPWV with the reference technique by tonometry. Our hypothesis, based on physiological reasons, is that heart-carotid PWV will surpass carotid-femoral PWV as a biomarker of large artery stiffness.\n\nThe trial aims to demonstrate the equivalence between heart-carotid PWV measured by laser-doppler vibrometry (LDV) with the reference MRI measurement (4D-FLOW MRI). MRI, the gold standard comparator is technically demanding and uncomfortable for the patient, much more expensive and not applicable at the general population level. It is therefore likely that measurement by laser-doppler vibrometry, without contact, more comfortable, acceptable and fast, could replace MRI for mass applications.\n\nFor this, we include 100 consecutive patients, 50 women, 50 men, scheduled for clinically indicated thoracic aorta MRI.\n\nENDPOINTS\n\nPrimary endpoint:\n\n• Heart-carotid PWV measured by LDV. To evaluate the agreement between heart-carotid PWV measured by LDV and the same measurement made by MRI (plus 4D-FLOW MRI) of the thorax.\n\nSecondary endpoints:\n\n* Reproducibility of the LDV hcPWV\n* Measurement of LDV cfPWV compared with tonometry\n* Association between PWV (hc, cf, LDV, MRI), and age, other risk factors\n* Assessment of patient acceptability of the measurement\n\nStatistical analysis The statistical technique used will be the Bland - Altman plot and the corresponding bias assessment (mean Bland-Altman bias and limits of agreement, defined as the mean bias ±1.96 - standard deviation, are provided); the coefficient of variation (CV) will also be used.\n\nDescription of the device being investigated:\n\nThe LDV device, developed by the European consortium CARDIS (Medtronic,SIOS, iMEC, Tyndall Institute) uses two arrays with 6 laser beams. It is a non-invasive exploration, by category 1 laser without any risk for the patient and allows to measure the local arterial stiffness (to evaluate the heart-carotid PWV) and segmental without contact with the skin by using the LDV technique. In practice, this device allows the evaluation of the hcPWV from the measurement of skin vibrations on the chest and neck.\n\nDescription of the device used as a comparator:\n\nThe reference technique is MRI, used in combination with 4D-FLOW MRI, an innovative technique that allows full 3-dimensional anatomical coverage as well as velocity coding in all 3 directions, opening new and unique possibilities for visualizing and quantifying complex cardiovascular blood flow'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 90 years of age in both sexes, who visit the hospital for MRI thoracic MRI as part of routine care.\n* Enrolled in a social security plan or beneficiary of such a plan.\n* Free, informed, written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any examination required by the research).\n\nand before any examination required by the research and even before the thoracic MRI planned in the care setting).\n\nExclusion Criteria:\n\n* Individuals under court protection, guardianship or under curator.\n* MRI examination done in an emergency context\n* Patients with skin lesions (severe eczema, wounds, etc.) in the thorax or neck that do not allow the application of not allowing the application of the skin protection film on the area of interest;\n* Allergies to the adhesive film.\n* Patients who have a beard, which would make it difficult to apply an adhesive cast.\n* Subjects who are not affiliated with social security or an equivalent plan.\n* Refusal or linguistic or psychic incapacity to read the information and not object to the research.\n* Patients with a serious pathology threatening the vital prognosis in the short and medium term (cancer metastatic cancer, end-stage renal failure, end-stage liver failure, end-stage heart failure) heart failure).\n* Patients with a history of acute severe (II, IV) heart failure.\n* Patients with progressive cardiovascular pathologies (unstable coronary artery disease, severe valvular disease,stroke, aortic dissection).\n* Rhythm disorders: atrial fibrillation, high degree auriculoventricular block.\n* Pregnant or breastfeeding women\n* Person subject to an exclusion period for another research'}, 'identificationModule': {'nctId': 'NCT05711693', 'acronym': 'InSide-CC', 'briefTitle': 'Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Integrated Silicon Photonics for Cardiovascular Disease Monitoring InSiDe-CC Clinical Validation of the Diagnostic Device (LDV) for the Measurement of Heart-carotid Pulse Wave Velocity (PWV) by Magnetic Resonance Imaging (MRI)', 'orgStudyIdInfo': {'id': 'C21-28'}, 'secondaryIdInfos': [{'id': '2021-A02896-35', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technique comparison', 'description': 'All patients will undergo successively LDV heart to carotid PWV and ascending aorta PWV by MRI, for comparison', 'interventionNames': ['Device: Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV)', 'Procedure: Blood pressure and heart rate measurement', 'Device: carotid to femoral PWW measurement', 'Procedure: Questionnaire completion']}], 'interventions': [{'name': 'Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV)', 'type': 'DEVICE', 'description': 'Patients scheduled for thoracic aorta MRI will have LDV measurement of ccPWV. Both techniques will be compared', 'armGroupLabels': ['Technique comparison']}, {'name': 'Blood pressure and heart rate measurement', 'type': 'PROCEDURE', 'description': 'To all patients:\n\n\\- blood pressure and heart rate will be measured', 'armGroupLabels': ['Technique comparison']}, {'name': 'carotid to femoral PWW measurement', 'type': 'DEVICE', 'description': 'To all patients:\n\n\\- carotid to femoral PWW will be measured by LDV and tonometry for comparison', 'armGroupLabels': ['Technique comparison']}, {'name': 'Questionnaire completion', 'type': 'PROCEDURE', 'description': 'All patients will complete a questionnaire of acceptability', 'armGroupLabels': ['Technique comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre Boutouyrie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Européen Georges-Pompidou'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}