Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-01 @ 11:30 PM
Study NCT ID:
NCT02312193
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2014-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2014-11-28', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myogenic tone measured by micromyographic technique to evaluate small-artery morphology.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['hypertension', 'myogenic tone'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive patients and to better understand the mechanisms controlling the myogenic tone. Evaluations will be performed through ex vivo studies of peripheral arterioles in human adipose tissue from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the myogenic function in response to progressive blood pressure increases, in order to correlate myogenic function to arterial hypertension and to the molecular mechanisms already identified in the preclinical models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be selected from patients hospitalized in the Department of Neurosurgery of the IRCCS Mediterranean Neurological Institute Neuromed, according to specific inclusion criteria and undergoing surgery for disc disease. Subjects included in the study will be normotensive and hypertensive patients. Approximately 70 subjects of both genders (35 normotensive, 35 hypertensive) aged between 30 and 70 years old will be included in the study. All the enrolled patients must have an indication for neurosurgical intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females between 30 and 70 years of age\n* Hypertensive patients: Patients with a previous diagnosis of hypertension\n* Normotensive patients: subjects without story of hypertension\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe hypertension (eg, systolic \\>180 mm Hg, diastolic \\>110 mm Hg)\n* Manifested or suspected secondary hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, pheochromocytoma)\n* History of cardiac complications (previous acute myocardial infarction (AMI), unstabile angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), congestive heart failure (NYHA II-IV))\n* Diabetes mellitus\n* Renal pathologies (creatinine clearance \\< 30 ml/min)\n* Severe hepatic dysfunction'}, 'identificationModule': {'nctId': 'NCT02312193', 'briefTitle': 'Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Neuromed IRCCS'}, 'officialTitle': 'Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects', 'orgStudyIdInfo': {'id': 'LMB02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Hypertensive subjects'}, {'label': 'Control', 'description': 'Normotensive subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86077', 'city': 'Pozzilli', 'state': 'Isernia', 'country': 'Italy', 'facility': 'IRCCS Neuromed', 'geoPoint': {'lat': 41.51142, 'lon': 14.06252}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuromed IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph', 'investigatorFullName': 'Giuseppe Lembo', 'investigatorAffiliation': 'Neuromed IRCCS'}}}}