Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT03504956
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D003287', 'term': 'Contrast Media'}, {'id': 'C090600', 'term': 'gadobutrol'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'D008790', 'term': 'Metoprolol'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque to Myocardial Ratio (PMR).', 'timeFrame': 'Day 1', 'description': 'PMR is defined as the ratio between the maximal signal intensity from a vessel wall region and the average signal from an adjacent myocardial area. Such metric is used to classify hyper-intense plaques, also known as "hot spots", which has PMR over 1.0.'}], 'secondaryOutcomes': [{'measure': 'Stenosis level (patient group only)', 'timeFrame': 'Day 1', 'description': 'Stenosis level will be evaluated at the vascular segments with visible lumen narrowing in each patient. The extent of a stenosis will be measured and recorded as a percentage, ranging from 0% to 100%, with 100% representing a complete occlusion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MRI technique', 'High Resolution MRI Technique'], 'conditions': ['Coronary Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.', 'detailedDescription': 'Approximately 110 healthy male/female adult "normals" or "controls" and 40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease will be recruited. All subjects will be asked to undergo either a non-contrast MRI or a contrast-enhanced MRI of the coronary artery depending upon the focus of development at the time of their participation\n\nIt is anticipated that healthy volunteers will undergo non-contrast or contrast-enhanced MRI for evaluating the image quality associated with each acquisition module of the developed technique and motion artifact associated with motion compensation strategy. For subjects receiving contrast, a total dose of up to 0.2 mmol/kg of a gadolinium based contrast agent will be injected intravenously provided all the safety requirements are met.\n\nSubjects undergoing a contrast-enhanced MRI will be screened using the standard clinical protocol to determine whether it is safe to administer contrast. If subjects do not qualify for contrast administration, they may be asked to have a research scan without contrast.\n\nResearch MRI results will be compared with clinical diagnostic CT and/or invasive imaging studies for patients who have been evaluated with these exams at Cedars-Sinai Medical Center..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* Healthy Volunteers: male or female ≥ 18 years of age with a BMI\\<30, with no history of cardiovascular disease\n* Patients: Medically stable, male or female ≥ 18 years of age who is have not suspected of having or has been diagnosed with coronary artery disease and undergone stenting or bypass surgery\n\nExclusion:\n\n* Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.\n* Inability to tolerate MR imaging secondary to an inability to hold breath for a short time or have claustrophobia.\n* Non-compliant with visit instructions, including following procedure instructions\n* Severe allergy to animal dander or animal-instigated asthma\n* Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR \\<45ml/min) or previous allergic reaction to gadolinium-based contrast agents.\\*\n* Volunteers who have had four or more prior previous gadolinium contrast scan'}, 'identificationModule': {'nctId': 'NCT03504956', 'acronym': 'CATCH', 'briefTitle': 'Coronary Atherosclerosis T1-Weighted Characterization (CATCH)', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Coronary Atherosclerosis T1-Weighted Characterization (CATCH)', 'orgStudyIdInfo': {'id': '45312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Volunteers', 'description': 'Approximately 110 healthy male/female adult "normals" or "controls" will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.', 'interventionNames': ['Device: Cardiac MRI', 'Drug: Contrast', 'Drug: Beta blocker']}, {'type': 'OTHER', 'label': 'Coronary Artery Disease (CAD) Patients', 'description': '40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease (CAD) will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.', 'interventionNames': ['Device: Cardiac MRI', 'Drug: Contrast', 'Drug: Beta blocker']}], 'interventions': [{'name': 'Cardiac MRI', 'type': 'DEVICE', 'otherNames': ['Magnetic Resonance Imaging'], 'description': 'MRI with/without administration of a contrast agent and beta-blocker based upon the stage of method development, if no contraindications are present.', 'armGroupLabels': ['Coronary Artery Disease (CAD) Patients', 'Healthy Volunteers']}, {'name': 'Contrast', 'type': 'DRUG', 'otherNames': ['contrast agent', 'Gadavist'], 'description': 'The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).', 'armGroupLabels': ['Coronary Artery Disease (CAD) Patients', 'Healthy Volunteers']}, {'name': 'Beta blocker', 'type': 'DRUG', 'otherNames': ['Metoprolol'], 'description': "Based upon the focus of the study at the time of the scan, a beta- blocker (metoprolol), in pill form based upon blood pressure and heart rate, may be administered to some subjects to improve the heart's ability to relax and slow the heart rate. The slower heart rate may improve image quality and lessen motion artifact.", 'armGroupLabels': ['Coronary Artery Disease (CAD) Patients', 'Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rhona Littman', 'role': 'CONTACT', 'email': 'Rhona.Littman@cshs.org', 'phone': '310 423-4387'}, {'name': 'Debiao Li, PhD', 'role': 'CONTACT', 'email': 'Debiao.Li@cshs.org', 'phone': '310 423-7743'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Rosalia (Sally) A De Leon', 'role': 'CONTACT', 'email': 'Rosalia.DeLeon@cshs.org', 'phone': '310 423-7758'}, {'name': 'Debiao Li, PhD', 'role': 'CONTACT', 'email': 'debiao.li@cshs.org', 'phone': '310 423-7743'}], 'overallOfficials': [{'name': 'Debiao Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Biomedical Imaging Research Institute', 'investigatorFullName': 'Debiao Li, PhD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}