Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-03 @ 1:14 PM
Study NCT ID:
NCT03438500
Status:
WITHDRAWN
Last Update Posted:
2022-10-31
First Post:
2018-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'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'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor \\& PI decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of myocardial perfusion reserve (MPR)', 'timeFrame': '14 weeks', 'description': 'Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks'}, {'measure': 'Change of myocardial perfusion reserve (MPR)', 'timeFrame': '5 weeks', 'description': 'Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 5 weeks'}], 'secondaryOutcomes': [{'measure': 'Enddiastolic volume', 'timeFrame': '5 weeks', 'description': 'Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks'}, {'measure': 'Enddiastolic volume', 'timeFrame': '14 weeks', 'description': 'Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks'}, {'measure': 'Endsystolic volume', 'timeFrame': '5 weeks', 'description': 'Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks'}, {'measure': 'Endsystolic volume', 'timeFrame': '14 weeks', 'description': 'Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks'}, {'measure': 'Stroke volume', 'timeFrame': '5 weeks', 'description': 'Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks'}, {'measure': 'Stroke volume', 'timeFrame': '14 weeks', 'description': 'Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks'}, {'measure': 'Ejection fraction', 'timeFrame': '5 weeks', 'description': 'Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks'}, {'measure': 'Ejection fraction', 'timeFrame': '14 weeks', 'description': 'Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks'}, {'measure': 'Regional wall motion', 'timeFrame': '5 weeks', 'description': 'Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks'}, {'measure': 'Regional wall motion', 'timeFrame': '14 weeks', 'description': 'Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks'}, {'measure': 'Scar extent', 'timeFrame': '5 weeks', 'description': 'Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks'}, {'measure': 'Scar extent', 'timeFrame': '14 weeks', 'description': 'Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks'}, {'measure': 'Diffuse fibrosis', 'timeFrame': '5 weeks', 'description': 'Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks'}, {'measure': 'Diffuse fibrosis', 'timeFrame': '14 weeks', 'description': 'Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks'}, {'measure': 'Severity and frequency of angina', 'timeFrame': '5 weeks', 'description': 'Change from baseline in Seattle Angina questionnaire at 5 weeks'}, {'measure': 'Severity and frequency of angina', 'timeFrame': '14 weeks', 'description': 'Change from baseline in Seattle Angina questionnaire at 14 weeks'}, {'measure': 'New York Heart Association (NYHA) class', 'timeFrame': '5 weeks', 'description': 'Change from baseline in NYHA class at 5 weeks'}, {'measure': 'New York Heart Association (NYHA) class', 'timeFrame': '14 weeks', 'description': 'Change from baseline in NYHA class at 14 weeks'}, {'measure': 'Exercise capacity', 'timeFrame': '5 weeks', 'description': 'Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks'}, {'measure': 'Exercise capacity', 'timeFrame': '14 weeks', 'description': 'Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks'}, {'measure': 'Quality of life (SF-36)', 'timeFrame': '5 weeks', 'description': 'Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 5 weeks'}, {'measure': 'Quality of life (SF-36)', 'timeFrame': '14 weeks', 'description': 'Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 14 weeks'}, {'measure': 'New myocardial scarring or fibrotic changes', 'timeFrame': '5 weeks', 'description': 'Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 5 weeks'}, {'measure': 'New myocardial scarring or fibrotic changes', 'timeFrame': '14 weeks', 'description': 'Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 14 weeks'}, {'measure': 'Myocardial edema', 'timeFrame': '5 weeks', 'description': 'Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks'}, {'measure': 'Myocardial edema', 'timeFrame': '14 weeks', 'description': 'Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks'}, {'measure': 'Myocardial hemorrhage', 'timeFrame': '5 weeks', 'description': 'Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks'}, {'measure': 'Myocardial hemorrhage', 'timeFrame': '14 weeks', 'description': 'Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory Angina Pectoris', 'Ischemic Heart Disease', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.', 'detailedDescription': 'This is a mono-center, prospective, single arm, pilot study designed to assess the feasibility of the "Cardiac Shock Wave Treatment" in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.\n\nA total of 10 subjects will be enrolled in the study. All enrolled study subjects will be assessed for clinical follow-up at the following intervals: 5 and 14 weeks post CSWT procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of anginal chest pain that prompted a myocardial stress test (nuclear myocardial perfusion imaging, stress echocardiography, or perfusion CMR)\n* Evidence for stress-induced myocardial ischemia in this examination\n* Coronary angiogram showing absence of ≥30% stenosis of epicardial coronary arteries\n\nExclusion Criteria:\n\n* Participation in other clinical trials\n* age \\<18 years\n* Contraindications to under cMRI\n* Contraindications to adenosine (severe chronic obstructive pulmonary disease (COPD), asthma, atrioventricular block (AV block) \\> grade 1)\n* Left ventricular thrombus\n* Uncontrolled diabetes mellitus\n* Uncontrolled arterial hypertension,\n* Any other severe chronic illness such as liver or renal failure (glomerular filtration rate (GFR) \\< 45 ml/min), active neoplastic disease, history of myocardial infarction or coronary revascularization within the past three months\n* Patients with pacemaker or implanted cardioverter defibrillator\n* Patients after valve surgical replacement\n* Patients after interventional valve replacement or reconstruction (e.g. transfemoral aortic valve replacement or MitraClip implantation)\n* Pregnancy (a reliable method of contraception must be used for the entire duration of the study)\n* Fertile female participants who are capable of bearing children and who do not use a method of contraception that is medically approved by the health authority of the respective country\n* Missing capacity to consent'}, 'identificationModule': {'nctId': 'NCT03438500', 'briefTitle': 'Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve', 'organization': {'class': 'INDUSTRY', 'fullName': 'Storz Medical AG'}, 'officialTitle': 'The Impact of Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve in the Absence of Epicardial Coronary Artery Stenoses: A Pilot Study', 'orgStudyIdInfo': {'id': 'CSW-1814-SCH-0010-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Shockwave Therapy', 'description': 'Patients in this group receive shockwave therapy.', 'interventionNames': ['Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)']}], 'interventions': [{'name': 'Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)', 'type': 'DEVICE', 'otherNames': ['Modulith SLC', 'Extracorporeal Cardiac Shockwave Therapy (CSWT)'], 'description': '40 - 60 spots per visit (200 shots/spot) at Energy Level 3', 'armGroupLabels': ['Active Shockwave Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Technische Universität München I. Medizinische Klinik und Poliklinik', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Georg Schmidt, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technische Universität München I. Medizinische Klinik und Poliklinik'}, {'name': 'Alexander Steger, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technische Universität München I. Medizinische Klinik und Poliklinik'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Storz Medical AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Technical University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}