[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Scripps Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100630703","the-cdac-study---cerebral-dysfunction-after-coronary-revascularization-100630703",false,"NCT07491120","The CDAC Study - Cerebral Dysfunction After Coronary Revascularization","CDAC","Inclusion Criteria:\n\n* Criteria for enrollment are age 18 years or more.\n* A candidate for either elective single or multi-vessel CABG or PCI without limits for lesion location, lesion characteristics or complexity, the number of vessels treated, or the number of stents or bypass grafts placed, or the type of bypass grafts.\n* The decision to undergo either CABG or PCI will be made by the treating physician and patient before research study enrollment, and thus, the revascularization decision is not directed by this research protocol.\n\nExclusion Criteria:\n\nPatients will not be enrolled due to:\n\n* Concomitant valve therapy (surgical or transcatheter).\n* Prior CABG or surgical valve repair\u002Freplacement surgery.\n* PCI within 1 year of the study entry procedure.\n* A hybrid revascularization procedure (PCI plus CABG), an untreated carotid artery stenosis of \\>70%, inability to provide informed consent.\n* The inability to perform pre-procedure tablet-based neurocognitive testing.\n* The lack of stated agreement to return for follow-up on-site neurocognitive testing at the prescribed time points.","ALL","18 Years",{"count":19,"type":20},600,"ESTIMATED","OBSERVATIONAL","Neurocognitive decline has long been suspected to be a potential long-term complication of coronary artery bypass grafting surgery (CABG), with reports of post-operative cognitive dysfunction by objective testing approaching 15-50% of patients in the year following surgery. To determine the true rate of long-term cognitive dysfunction following CABG compared to percutaneous coronary intervention (PCI or coronary stent placement), we propose a multi-center, two-group, non-randomized study using computer-based customized neurocognitive testing (Cogsate), prior to the procedure and then at 30 days, 1-year and 2-years after revascularization to evaluate cognitive function vital for the maintenance and advancement of professional and personal activities. It is anticipated that the study will document a higher rate of cognitive dysfunction in the CABG group, that the landmark study will provide both the patient and physician with the information necessary to make an informed decision regarding the cognitive risks of CABG versus PCI when faced with the need for coronary revascularization, and that these results will change the clinical practice of recommending CABG as a primary revascularization option for those wishing to preserve cognitive function.",[24,25,26],"CABG","PCI","Cognitive Decline",[24,25,26],"NOT_YET_RECRUITING","2026-03-19",{"date":31,"type":32},"2026-03-24","ACTUAL",{"date":34,"type":20},"2027-01-01",{"date":36,"type":20},"2033-01-01",{"name":38,"class":39},"The Scripps Research Institute","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100607528","the-magnasafe-2-registry-assessing-the-risks-of-magnetic-resonance-imaging-in-three-patient-groups-100607528","NCT07189728","The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups","The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups: (1) an MRI at a Magnet Field Strength of 3-tesla, (2) a \"Mixed-vendor\" or a Same Vendor \"Mixed-component\" Platform at 1.5-tesla or 3-tesla, or (3) a System With an Abandoned, Epicardial, or Fractured Lead at 1.5-tesla.","Inclusion Criteria:\n\nPatients will be included in the registry if they fulfill all the following criteria:\n\n1. Age of 18 years or older\n2. Able to provide informed consent for entry in the research registry\n3. Have a CIED from any manufacturer implanted after 2001\n4. Have cardiac leads from any manufacturer without an implant date limitation\n5. Documentation that the patient's ordering physician has determined that an MRI at 1.5-tesla or 3.0-tesla of any anatomic region is clinically indicated without an acceptable alternative imaging technology\n6. The patient is scheduled for that imaging procedure\n7. MRI will be performed for clinical purposes, and not for the purpose of entry into this research protocol\n8. In addition, groups within the protocol require that an enrolled patient will have:\n\n   1. An NMRC CIED scheduled for MRI at 3.0-tesla with a CIED that is not MRC at that field strength.\n   2. A \"mixed-vendor\" or same vendor \"mixed-component\" system that is NMRC because the generator and lead combination are not labeled as MRC for use in the MR-environment.\n   3. A CIED and abandoned lead, a fractured cardiac lead, an epicardial lead, or a subcutaneous array.\n\n      Exclusion Criteria:\n\n      Patients will not be included in the registry if they fulfill any of the following criteria:\n\n   \u003C!-- -->\n\n   1. A generator battery at the elective replacement indicator (ERI)\n   2. Renal insufficiency (GFR \\\u003C45 cc\u002Fmin)\n   3. In addition, all standard clinical exclusion criteria for MRI in patients without a cardiac device will be observed.\n   4. Standard clinical exclusion criteria include pregnancy, severe claustrophobia (not responsive to pre-procedure medications), morbid obesity (abdominal diameter of greater than 60 cm), and the presence of ferro-magnetic metallic objects (such as intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils)\n\n      \\-",{"count":48,"type":20},1500,"6 Months","SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been published by the Heart Rhythm Society, and the Medicare National Coverage Determination (NCD) has been modified to provide coverage for these patients (CAG-00399R4). However, for patients with an abandoned, epicardial, or fractured cardiac lead or subcutaneous array, with a \"mixed-vendor\" or same-vendor \"mixed-component\" CIED, or those undergoing MRI at 3.0-tesla with a device not labelled as MRI-conditional (MRC) for use at 3-tesla, the risks of MRI have not been determined.\n\nHypothesis: For patients with an MRC or NMRC pacemaker or defibrillator and specific indications or circumstances not presently addressed, the risks of MRI do not increase.\n\nPurpose: The MagnaSafe-2 Registry is designed to determine the risks of MRI in patients with limited MRI access not previously addressed in peer-reviewed literature and to improve access for approximately 70% of whom are predicted to have a future clinical need for MRI.\n\nStudy Design: A prospective registry of patients undergoing clinically indicated MRI. The protocol is being developed in collaboration with the FDA's Center for Devices and Radiological Health, and an Investigational Device Exemption is being requested for event reporting and monitoring. Also, \"Coverage with Evidence Development (CED)\" has been requested from CMS.\n\nEnrollment: Eligible patients are 18 years or older and have a MRC or NMRC pacemaker system from any manufacturer, (after 2001), with leads from any manufacturer (without date restriction), and if the ordering physician has determined that MRI is clinically indicated, the imaging method of choice, and NOT performed for the purpose of research. Exclusions are a leadless pacemaker, a device battery at \"elective replacement indicator,\" or renal insufficiency (GFR \\\u003C45 cc\u002Fmin). All participants will be required to provide informed consent for the collection of data.\n\nMethods: Patients will be enrolled in the registry at up to 30 clinical centers with: (1) an NMRC pacing system scheduled for MRI at a magnet field strength of 3-tesla, (2) an NMRC system due to a \"mixed-vendor\" or a same vendor \"mixed-component\" platform at 1.5-tesla or 3-tesla, or (3) an MRC or NMRC pacing system and an abandoned, epicardial, or fractured lead at 1.5-tesla.\n\nPrimary Endpoints: A new cardiac arrhythmia noted during the MRI scan, or a Troponin-T elevation (\\>upper limit of normal) at 18-24 hours post-MRI scan compared to baseline (obtained within 30 days before the MRI scan), Troponin-T levels pre-MRI. Secondary Endpoints: Death, generator or lead failure requiring immediate replacement, loss of pacing capture (pacing-dependent patients), partial or full generator-electrical reset, pacing lead threshold increase of ≥1.0 V, a P-wave amplitude decrease of ≥50%, an R-wave amplitude decrease of ≥50%, and a pacing lead impedance change of ≥50 ohms from baseline.\n\nSample Size: Using an event rate limit of ≤1%, 500 cases will be needed in each group to yield a 95% confidence interval of 0 to 1.0% if no events are observed. When a total of 500 cases have been enrolled in one group, enrollment in the other groups may be continued at the discretion of the investigators. The estimated study duration is 5 years, including enrollment and data analysis.\n\nClinical Implications and Impact: The anticipated results will support an amendment to the current HRS Expert Consensus Statement (2017) and Medicare NCD (April 2018) for the patient groups in the study.",[52,53,54],"Pacemakers","MRI Imaging","Implantable Cardioverter Defibrillator (ICD)",[56,57,58,59,60],"pacemaker","MRI","implantable cardioverter defibrillator","abandoned cardiac leads","3-tesla","2025-09-22",{"date":63,"type":32},"2025-09-24",{"date":65,"type":20},"2026-01-01",{"date":67,"type":20},"2031-01-01",{"name":38,"class":39},""]