Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-26 @ 12:21 AM
Study NCT ID:
NCT07002450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2025-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-30', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost effectiveness', 'timeFrame': 'Emergency department presentation to 30 days', 'description': 'Cost effectiveness between CCT strategy and standard of care'}], 'primaryOutcomes': [{'measure': 'Primary composite outcome', 'timeFrame': 'Randomization to 30 days', 'description': 'Using a hierarchical win ratio:\n\n1. All-cause death\n2. Stroke, transient ischemic attack, or systemic embolism\n3. Admission to hospital for a cardiac reason (ex. heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome)\n4. Number of repeat presentations to hospital for a cardiac reason (ex. heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome)\n5. Improvement in AF Effect On Quality-Of-Life Questionnaire (AFEQT) quality of life greater than or equal to 5 points\n6. Presence of sinus rhythm at 30 days'}], 'secondaryOutcomes': [{'measure': 'Composite secondary outcome', 'timeFrame': 'Randomization to 30 days', 'description': 'Using a hierarchical win ratio:\n\n1. All-cause death\n2. Stroke, transient ischemic attack, or systemic embolism\n3. Admission to hospital for a cardiac reason (ex. heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome)\n4. Number of repeat presentations to hospital for a cardiac reason (ex. heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome)\n5. Improvement in AF Effect On Quality-Of-Life Questionnaire (AFEQT) quality of life greater than or equal to 5 points'}, {'measure': 'Composite objective outcomes', 'timeFrame': 'Randomization to 30 days', 'description': 'Using a hierarchical win ratio:\n\n1. All-cause death\n2. Stroke, transient ischemic attack, or systemic embolism\n3. Admission to hospital for a cardiac reason (ex. heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome)\n4. Number of repeat presentations to hospital for a cardiac reason (ex. heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome)'}, {'measure': 'All-cause death', 'timeFrame': 'Randomization to 30 days', 'description': 'Death from any cause'}, {'measure': 'Cardiovascular death', 'timeFrame': 'Randomization to 30 days', 'description': 'Death due to a cardiovascular cause'}, {'measure': 'Stroke, transient ischemic attack, or systemic embolism', 'timeFrame': 'Randomization to 30 days', 'description': 'Stroke is defined as a central nervous system infarction of the brain, spinal cord, or retina in a vascular distribution based on pathologic, imaging, or clinical evidence with symptoms persisting for ≥24 hours or until death.\n\nTransient ischemic attack is defined as a transient episode of neurologic dysfunction due to focal brain, spinal cord, or retinal ischemia without acute infarction or tissue injury.\n\nSystemic embolism is defined as an abrupt vascular insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms.'}, {'measure': 'Hospital admission for a cardiac reason', 'timeFrame': 'Randomization to 30 days', 'description': 'Hospitalization due to a cardiac reason such as heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome'}, {'measure': 'Repeat presentation to the emergency department', 'timeFrame': 'Randomization to 30 days', 'description': 'Repeat presentation to the emergency department due to a cardiac reason such as heart failure, syncope, palpitations/arrhythmia, angina or acute coronary syndrome'}, {'measure': 'AFEQT quality of life', 'timeFrame': 'Randomization to 30 days', 'description': 'Change in AF Effect On Quality-Of-Life Questionnaire (AFEQT) quality of life The AFEQT is a 20-item, self-administered instrument that quantifies symptoms, daily activities, treatment concern, and treatment satisfaction. Scores are transformed to a range from 0-100, in which higher scores reflect better health status.'}, {'measure': 'SF-36 quality of life', 'timeFrame': 'Randomization to 30 days', 'description': 'Change in 36-Item Short Form Health Survey (SF-36) quality of life. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Bleeding', 'timeFrame': 'Randomization to 30 days', 'description': 'Bleeding events as defined by the Bleeding Academic Research Consortium'}, {'measure': 'Admission to hospital for acute kidney injury', 'timeFrame': 'Randomization to 30 days', 'description': 'Definition of acute kidney injury according to the Kidney Disease Improving Global Outcomes:\n\n* Increase in SCr by ≥ 0.3 mg/dl (≥ 26.5 µmol/l) within 48 hours; or\n* Increase in SCr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or\n* Urine volume \\<0.5 ml/kg/h for 6 hours'}, {'measure': 'Length of stay in the emergency department', 'timeFrame': 'From time of arrival until time of discharge or admission (approximately 3 hours)', 'description': 'Length of stay in emergency department in minutes, from time of arrival to time of discharge or admission'}, {'measure': 'Normal sinus rhythm', 'timeFrame': 'At the time of patient disposition (approximately 3 hours after arrival)', 'description': 'Being in normal sinus rhythm at the time of emergency department disposition (discharge or admission). Heart rhythm will be determined by electrocardiography.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac computed tomography angiography', 'Cardioversion', 'Atrial flutter', 'Atrial fibrillation'], 'conditions': ['Atrial Fibrillation (AF)', 'Atrial Flutter']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized clinical trial is to learn whether patients with symptomatic atrial fibrillation or atrial flutter (AF) who require heart imaging to rule out a blood clot before cardioversion would benefit from cardiac computed tomography angiography (CCT) in the emergency department (ED) compared to current standard of care management.\n\nThis will be a multicenter trial evaluating whether CCT-facilitated cardioversion in the ED reduces hospital admission, reduces repeat presentations to hospital and improves patient quality of life compared to the current standard of care.\n\nParticipants will undergo CCT-facilitated cardioversion or be treated according to current standard of care while in the ED and complete quality of life questionnaires in the ED and follow-up at 30 days.', 'detailedDescription': 'Atrial fibrillation and atrial flutter (AF) are the most common cardiac arrhythmias worldwide resulting in frequent visits to the emergency department (ED). Some patients can undergo chemical or electrical cardioversion to restore their heart back to a sinus rhythm. However, if a patient is not on blood thinners and the duration of AF is prolonged then blood clots may form in the heart increasing the risk of stroke after cardioversion. Therefore, some patients must undergo heart imaging to rule out any blood clots before cardioversion is considered safe. Transesophageal echocardiography (TEE) is commonly used to rule out blood clots, but it is not readily available in all EDs often resulting in hospital admission to facilitate this test or deferring cardioversion until 3 weeks of blood thinners have been completed.\n\nCardiac computed tomography angiography (CCT) is a more readily available alternative to TEE that can be done rapidly in the ED. CCT has excellent sensitivity and specificity compared to TEE for identifying cardiac thrombus. If there is no thrombus detected on the CCT then patients could be immediately cardioverted to sinus rhythm thus avoiding an unnecessary hospital admission and reducing the symptom burden associated with remaining in AF.\n\nThis study is a multicenter randomized trial that will evaluate the effectiveness of using CCT facilitated cardioversion in the ED compared to current standard of care management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old; and\n2. Primary symptomatic AF without a reversible underlying cause (e.g. sepsis, pneumonia, pulmonary embolism, hyperthyroidism)\n3. LA imaging required before cardioversion according to local clinical practice guidelines\n\nExclusion Criteria:\n\n1. Patients with an indication for emergency cardioversion (e.g. hemodynamic instability (systolic blood pressure\\<90mmHg or signs of shock), cardiac ischemia (ongoing severe chest pain or marked ST depression on ECG \\>2mm), or pulmonary edema (significant dyspnea, crackles, or hypoxia)); or\n2. Contraindication to CCT (renal insufficiency (eGFR\\< 45ml/min/1.73m2), allergy to intravenous contrast agents, pregnancy (contraindications to radiation exposure), or inability to perform 20-second breath-hold)'}, 'identificationModule': {'nctId': 'NCT07002450', 'acronym': 'LA CLOTTED', 'briefTitle': 'Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)', 'orgStudyIdInfo': {'id': '20240752-01T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Patients in the control arm will be treated according to current standard of care as determined by the primary treating emergency department physician and may vary by institution and physician. Treatment in the standard of care group may include a rate control strategy with or without a planned cardioversion after 3 weeks of anticoagulation, deferring management for outpatient evaluation, request for TEE-facilitated cardioversion in the ED, or specialist consultation for further management or admission to hospital.', 'interventionNames': ['Other: Standard of care management']}, {'type': 'EXPERIMENTAL', 'label': 'CCT-facilitated cardioversion arm', 'description': 'Patients in this arm will undergo cardiac computed tomography angiography (CCT) to evaluate for a left atrial/left atrial appendage (LA) thrombus. If the CCT shows no LA thrombus then the emergency department physician will be able to perform electrical and/or chemical cardioversion at their discretion. If the CCT shows a LA thrombus then cardioversion will be contraindicated and further management will be at the discretion of the treating physician.', 'interventionNames': ['Diagnostic Test: Cardiac computed tomography angiography']}], 'interventions': [{'name': 'Cardiac computed tomography angiography', 'type': 'DIAGNOSTIC_TEST', 'description': "Patients will undergo CCT according to the following protocol. A non-contrast enhanced prospective ECG-triggered image will be acquired followed by a contrast-enhanced prospective ECG-triggered image using a tri-phasic contrast protocol. Delayed CT images 60 seconds after the initial contrast-enhanced CT scan will be obtained. Cardiac CT image interpretation will be performed according to routine clinical practices in a pragmatic fashion. The LA will be assessed for filling defects and characterized based upon attenuation values. If LA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. If the CCT shows no LA thrombus then the ED physician will be able to perform electrical and/or chemical cardioversion at their discretion.", 'armGroupLabels': ['CCT-facilitated cardioversion arm']}, {'name': 'Standard of care management', 'type': 'OTHER', 'description': 'Patients in the standard of care arm may undergo any combination of the following management strategies in the emergency department (ED) at the discretion of their treating physician:\n\n1\\. Transesophageal echocardiogram (TEE) facilitated cardioversion; 2. Rate control; 3. Consultation with inpatient cardiac specialist for assessment/management and consideration of hospital admission; 4. cardioversion after 3 weeks of anticoagulation; and/or 5. Outpatient referral to cardiac specialist or general practitioner for further management.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 1J8', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Ian Stiell, MD', 'role': 'CONTACT', 'email': 'istiell@ohri.ca', 'phone': '613-798-5555', 'phoneExt': '18683'}, {'name': 'Ian Stiell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ottawa Hospital Civic Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Farrah Ahmed', 'role': 'CONTACT', 'email': 'fahmed@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '12697'}, {'name': 'Yeung Yam', 'role': 'CONTACT', 'email': 'yyam@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '19703'}], 'overallOfficials': [{'name': 'Benjamin Chow, MD PhD FRCPC FACC FESC FA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Mehrdad Golian, MD MSC FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Study completion', 'ipdSharing': 'YES', 'description': 'The study data, protocol, SAP, ICF, and CSR will be made available at study completion/publication.', 'accessCriteria': 'The above will be made publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}