Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00231205
Status:
UNKNOWN
Last Update Posted:
2005-10-04
First Post:
2005-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TDI Preejection Velocities and Myocardial Viability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2009-12'}, 'lastUpdateSubmitDate': '2005-09-30', 'studyFirstSubmitDate': '2005-09-30', 'studyFirstSubmitQcDate': '2005-09-30', 'lastUpdatePostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['viability', 'myocardium', 'preejection velocity', 'CAD', 'echocardiography', 'tissue Doppler'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test accuracy of positive preejection velocity to predict left ventricular remodeling and long-term prognosis after revascularization in 200 patients with chronically dysfunctional myocardium. Patients will be followed for 3 years.\n\nOur hypothesis is that tissue-Doppler-derived analysis of positive preejection velocity allows to select optimal responders to revascularization; it means individuals with the greatest benefit in terms of LV remodeling and long-term prognosis.', 'detailedDescription': 'The objective of the project is to study clinical and prognostic value of new echocardiographic technique, so called positive preejection velocity (+VIC), in patients with chronic ischemic left ventricular (LV) dysfunction indicated for revascularization. Pilot studies has shown high accuracy of pulsed Tissue Doppler imaging (TDI)-derived resting pattern of +VIC to detect viable myocardium in patients with both acute myocardial infarction and chronically dysfunctional myocardium. The aim of the project is to test accuracy of +VIC to predict LV remodeling and long-term prognosis after revascularization in patients with chronically dysfunctional myocardium. Study population will consist of two groups of patients with stable ischemic LV dysfunction: group A- patients indicated for revascularization (n=200), group B- matched control group treated conservatively (case-control design) (n=100). All patients will be followed for 3 years. Endpoints include: 1) LV remodeling at 6 and 24 months and 2) MACE at 6, 12 and 36 months follow-up. Our hypothesis is that TDI-derived analysis of +VIC allows to select optimal responders to revascularization; it means individuals with the greatest benefit in terms of LV remodeling and long-term prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. occluded or suboccluded left anterior descending coronary artery (LAD) at recent coronary angiography (\\< 3 months);\n2. LV ejection fraction \\< 40%;\n3. 3 and more akinetic or severely hypokinetic segments in the LAD perfusion territory at resting echocardiography.\n\nExclusion Criteria:\n\n\\- Patients with recent acute coronary syndrome, atrial fibrillation, bundle branch block, LV hypertrophy or aneurysm, significant valvular disease, pacemakers or internal defibrillators, poor echocardiographic image quality and contraindications for MRI are excluded.'}, 'identificationModule': {'nctId': 'NCT00231205', 'briefTitle': 'TDI Preejection Velocities and Myocardial Viability', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'TDI-Derived Myocardial Preejection Velocities in Patients With Chronic Ischemic Left Ventricular Dysfunction Undergoing Surgical Revascularization', 'orgStudyIdInfo': {'id': 'IGA 8524-5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Revascularization', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Martin Penicka, MD, PhD', 'role': 'CONTACT', 'email': 'penicka@fnkv.cz', 'phone': '+420 26716 2724'}, {'name': 'Petr Tousek, MD', 'role': 'CONTACT', 'email': 'tousek@email.cz', 'phone': '+420 26716 2724'}, {'name': 'Martin Penicka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'III. Internal-cardiological clinic, 3rd Medical Faculty, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Martin Penicka, MD, PhD', 'role': 'CONTACT', 'email': 'penicka@fnkv.cz', 'phone': '+420 26716 2724'}, {'name': 'Petr Tousek, MD', 'role': 'CONTACT', 'email': 'tousek@email.cz', 'phone': '+420 26716 2724'}], 'overallOfficials': [{'name': 'Martin Penicka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Prague, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Czech Republic', 'class': 'OTHER_GOV'}, {'name': 'Czech Ministry of Education', 'class': 'OTHER_GOV'}]}}}