Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-27 @ 5:37 PM
Study NCT ID:
NCT01361659
Status:
UNKNOWN
Last Update Posted:
2011-07-12
First Post:
2011-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shockwave Treatment for Advanced Angina in Maastricht
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-11', 'studyFirstSubmitDate': '2011-04-12', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of exercise tolerance', 'timeFrame': 'after 6 months', 'description': 'Modified Bruce protocol, changes compared to the baseline'}], 'secondaryOutcomes': [{'measure': 'Improvement of myocardial perfusion', 'timeFrame': '6 months', 'description': 'myocardial perfusion scintigraphy changes compared to the baseline'}, {'measure': 'Number of Patients with Adverse Events as a Measure of Safety', 'timeFrame': '6 months', 'description': 'Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain.'}, {'measure': 'Improvement of quality of life', 'timeFrame': '6 months', 'description': 'Number of anginal attacks/week, use of nitrates/week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anginal complaints', 'Lithotripsy', 'no option patients'], 'conditions': ['Angina']}, 'descriptionModule': {'briefSummary': 'There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.\n* Patients demonstrates exercise tolerance test (ETT) duration \\< 10 minutes on a modified Bruce protocol\n* No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)\n* Patient's conditions stable for at least 3 months\n* Life expectancy of \\> 12 months.\n\nExclusion Criteria:\n\n* Unstable angina pectoris\n* Haemodynamically significant valvular heart disease\n* Myocardial infarction \\<3 month prior randomization\n* Evidence of intracardiac thrombus\n* Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)\n* Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.\n* Patients who are unwilling or unable to cooperate with the study procedure.\n* Age \\< 18 years\n* Cardiac or pulmonary malignancy\n* No informed consent\n* Known depression"}, 'identificationModule': {'nctId': 'NCT01361659', 'acronym': 'SWAAM', 'briefTitle': 'Shockwave Treatment for Advanced Angina in Maastricht', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).', 'orgStudyIdInfo': {'id': '07-2-008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'shockwave treatment', 'type': 'PROCEDURE', 'description': '9 treatments in 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jindra Vainer, MD', 'role': 'CONTACT', 'email': 'J.Vainer@mumc.nl', 'phone': '+31433875106'}, {'name': 'H. Crijns, Prof Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Jindra Vainer, MD', 'role': 'CONTACT', 'email': 'J.Vainer@mumc.nl', 'phone': '+31433875106'}], 'overallOfficials': [{'name': 'H. Crijns, Prof Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medispec ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof Dr Harry Crijns', 'oldOrganization': 'Maastricht University Medical Center'}}}}