[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07224178":3,"trial-entities:NCT07224178":125,"trial-summary:NCT07224178":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":39,"secondary_outcomes":44,"sex":55,"minimum_age":56,"maximum_age":33,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":62,"locations":65,"central_contacts":85,"overall_officials":88,"references":92,"see_also_links":124},"NCT07224178","STUDY25010088","Left Atrial Strain and Cryptogenic Stroke","Left Atrial Strain: A Biomarker for Cryptogenic Stroke Prevention","RECRUITING","2027-12-31","2026-01","2026-01-07","2025-12-17","University of Pittsburgh","OTHER",false,"Cryptogenic stroke is a type of stroke in which the cause of the blood clot cannot be identified, leaving many patients without a clear treatment plan and at high risk for another stroke. Current medical guidelines recommend blood-thinning medication (anticoagulation) only when atrial fibrillation (AF) -an irregular heart rhythm- can be documented. However, AF may occur silently and remain undetected. Long term implantable (placed invasively under the skin) devices may be needed to capture these episodes.\n\nAF is known to develop from disease of the left atrium, the upper chamber of the heart that receives blood from the lungs. When the left atrium does not contract normally, blood flow may slow down, increasing the risk of clot formation. Nowadays, the left atrial (LA) function can be quantified precisely using a noninvasive ultrasound technique called strain imaging.\n\nThis study aims to determine whether reduced LA function is associated with cryptogenic stroke and its recurrence even when AF is not observed. If such an association is confirmed, LA strain could serve as a new biomarker to identify patients at risk, earlier than the development of overt AF, enhance preventive measures to reduce recurrent strokes. Because echocardiographic strain imaging is safe, cost-effective, and widely available, it may become an important tool for improving care in this high-risk population.","Cryptogenic stroke accounts for nearly one-third of ischemic strokes, yet its underlying mechanism often remains unidentified, leaving patients without targeted therapy. Atrial fibrillation (AF) is detected up to one third of cryptogenic strokes, but its detection frequently requires prolonged monitoring due to subclinical paroxysmal episodes. Increasing evidence suggests that structural and functional abnormalities of the left atrium (LA) precede AF and contribute to thromboembolic risk independently of rhythm disturbances.\n\nThis multicenter retrospective study aims to determine whether impaired LA strain, a sensitive echocardiographic measure of atrial function, is associated with cryptogenic stroke and can predict recurrent events. Echocardiographic images of the patients who were referred to the echocardiography laboratory as part of stroke work up will be analyzed offline, using standardized speckle-tracking software. De-identified clinical and imaging data will be collected in the central core laboratory at the University of Pittsburgh for uniform analysis and validation.\n\nBy establishing LA strain as a biomarker of atrial cardiopathy and cryptogenic stroke risk, this study seeks to bridge the current gap between stroke classification and management. Demonstrating the independent association between LA dysfunction and cryptogenic stroke and the recurrence of cryptogenic stroke independently of AF could support the use of LA strain as a risk marker to for monitoring patient and developing preventive strategies such as anticoagulation without documented AF. Hence, our findings may improve preventive care and reduce the burden of disabilities due to cryptogenic stroke.",[19,20,21,22,23],"Ischemic Stroke, Cryptogenic","Ischemic Stroke, Embolic","Hemorrhagic Stroke","Embolic Stroke of Undetermined Source","Recurrent Ischemic Stroke",[25,26,27,28,29,30,31],"stroke","embolic stroke of undetermined source","speckle-tracking echocardiography","left atrial cardiomyopathy","left atrial strain","recurrent ischemic stroke","new-onset atrial fibrillation","OBSERVATIONAL",null,[],{"count":36,"type":37},900,"ESTIMATED",[],[40],{"measure":41,"description":42,"timeFrame":43},"Correlation between left atrial strain (percent deformation) and the rate of cryptogenic stroke","Quantitative left atrial (LA) strain (% deformation), measured by speckle-tracking echocardiography from transthoracic echocardiograms obtained during stroke workup, will be compared with the rate of cryptogenic stroke.","Baseline",[45,49,52],{"measure":46,"description":47,"timeFrame":48},"Prediction of recurrent cryptogenic stroke by left atrial strain (percent deformation)","The number of recurrent cryptogenic stroke events during follow-up, as assessed by left atrial (LA) strain (% deformation) quantified at baseline echocardiogram.","Up to 1 year from date of index transthoracic echocardiography.",{"measure":50,"description":51,"timeFrame":48},"Incidence of cardiovascular and cerebrovascular mortality among patients with impaired LA strain (percent deformation)","The number of cardiovascular and cerebrovascular mortality during follow-up, as assessed by left atrial (LA) strain (% deformation) quantified at baseline echocardiogram.",{"measure":53,"description":54,"timeFrame":48},"Incidence of newly detected atrial fibrillation among patients with impaired LA strain","The number of new-onset atrial fibrillation during follow-up, as assessed by left atrial (LA) strain (% deformation) quantified at baseline echocardiogram.","ALL","18 Years",{"inclusion":58,"exclusion":60,"raw_text":61},[59],"Adult patients (age \\> 18 years and \\\u003C 80 years) who had a complete transthoracic echocardiography (TTE) exam at the University of Pittsburgh Medical Center (UPMC) Presbyterian Echocardiography Lab with a referral diagnosis of suspected stroke.",[],"Inclusion Criteria:\n\n* Adult patients (age \\> 18 years and \\\u003C 80 years) who had a complete transthoracic echocardiography (TTE) exam at the University of Pittsburgh Medical Center (UPMC) Presbyterian Echocardiography Lab with a referral diagnosis of suspected stroke.\n\n  2- Patients with an established diagnosis of stroke by stroke neurologists.\n\n  3- Patients in sinus rhythm documented at the time of referral.\n\n  4- Availability of adequate echocardiographic images for strain quantification.\n\n  5- Clinical follow-up data available for evaluation of study endpoints, including stroke recurrence, atrial fibrillation development, and mortality.\n\n  6- Patients from collaborating centers will be included with de-identified echocardiographic images and clinical data meeting the above criteria.\n\nExclusion Criteria:\n\nIncomplete or technically difficult transthoracic echocardiography (TTE) studies and studies from subjects younger than 18 years of age will be excluded. Additional exclusion criteria include:\n\n1- Pre-existing atrial fibrillation (AF): Patients with a documented history AF prior to the index echocardiography study will be excluded because it is well established that AF justifies cryptogenic stroke requiring anticoagulation.\n\n2 -Structural heart disease: Patients with significant structural abnormalities, such as moderate or severe mitral stenosis, moderate or severe mitral regurgitation, prosthetic heart valves, devices in the left atrium, atrial septal defect or patent foramen ovale will be excluded as these conditions are known causes of stroke and abnormal left atrial function.\n\n3- Coagulopathy: Patient having disease leading to hypercoagulable (thrombus formation) state will be excluded (presence of cancer, antiphospholipid antibodies, hematological diseases).\n\n4- Inadequate clinical follow-up: Patients with insufficient follow-up data or missing medical records that preclude evaluation of study endpoints (e.g., stroke recurrence, AF development) will be excluded unless death is documented.\n\n5- Poor image quality for strain analysis: Patients having echo exams with inadequate image quality that prevent reliable strain quantification will be excluded.\n\n\\-",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":82},"UPMC Presbyterian","Pittsburgh","Pennsylvania","15213","United States",[73,78],{"name":74,"role":75,"phone":76,"email":77},"Leyla E Sade, MD","CONTACT","412-215-3464","sadele2@upmc.edu",{"name":79,"role":75,"phone":80,"email":81},"Benay Ozbay, MD","412-450-2774","ozbayb@upmc.edu",{"lat":83,"lon":84},40.44062,-79.99589,[86,87],{"name":74,"role":75,"phone":76,"email":77},{"name":79,"role":75,"phone":80,"email":81},[89],{"name":74,"affiliation":90,"role":91},"University of Pittsburgh Medical Center","PRINCIPAL_INVESTIGATOR",[93,97,100,103,106,109,112,115,118,121],{"pmid":94,"type":95,"citation":96},"36534978","BACKGROUND","Maheshwari A, Norby FL, Inciardi RM, Wang W, Zhang MJ, Soliman EZ, Alonso A, Johansen MC, Gottesman RF, Solomon SD, Shah AM, Chen LY. Left Atrial Mechanical Dysfunction and the Risk for Ischemic Stroke in People Without Prevalent Atrial Fibrillation or Stroke : A Prospective Cohort Study. Ann Intern Med. 2023 Jan;176(1):39-48. doi: 10.7326\u002FM22-1638. Epub 2022 Dec 20.",{"pmid":98,"type":95,"citation":99},"40052267","Masini G, Wang W, Ji Y, Eaton A, Inciardi RM, Soliman EZ, Passman RS, Solomon SD, Shah AM, De Caterina R, Chen LY. Markers of Left Atrial Myopathy: Prognostic Usefulness for Ischemic Stroke and Dementia in People in Sinus Rhythm. Stroke. 2025 Apr;56(4):858-867. doi: 10.1161\u002FSTROKEAHA.124.047747. Epub 2025 Mar 7.",{"pmid":101,"type":95,"citation":102},"33206942","Sade LE, Keskin S, Can U, Colak A, Yuce D, Ciftci O, Ozin B, Muderrisoglu H. Left atrial mechanics for secondary prevention from embolic stroke of undetermined source. Eur Heart J Cardiovasc Imaging. 2022 Feb 22;23(3):381-391. doi: 10.1093\u002Fehjci\u002Fjeaa311.",{"pmid":104,"type":95,"citation":105},"39812172","Sade LE, Faletra FF, Pontone G, Gerber BLM, Muraru D, Edvardsen T, Cosyns B, Popescu BA, Klein A, Marwick TH, Cameli M, Saric M, Thomas L, Ajmone Marsan N, Fontes-Carvalho R, Podlesnikar T, Fontana M, La Gerche A, Petersen SE, Moharem-Elgamal S, Bittencourt MS, Vannan MA, Glikson M, Peichl P, Cochet H, Stankovic I, Donal E, Thomas D, Marta RS. The role of multi-modality imaging for the assessment of left atrium and left atrial appendage: a clinical consensus statement of the European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC). Eur Heart J Cardiovasc Imaging. 2025 Mar 3;26(3):385-413. doi: 10.1093\u002Fehjci\u002Fjeaf014.",{"pmid":107,"type":95,"citation":108},"38308431","Clark A, Ferkh A, Vandenberg J, Elhindi J, Thomas L. Altered left atrial metrics in patients with cryptogenic stroke: A systematic review and meta-analysis. Eur J Clin Invest. 2024 Jun;54(6):e14175. doi: 10.1111\u002Feci.14175. Epub 2024 Feb 2.",{"pmid":110,"type":95,"citation":111},"40608042","Ozbay B, Rearick C, Satyavolu BS, Soman P, Wong TC, Starr M, Pillai B, Zhu J, Azhar AZ, Katz WE, Sade LE. Primary Left Atrial Cardiopathy in Transthyretin Amyloidosis Cardiomyopathy by Multimodality Imaging: Implications for Thrombotic Events. JACC Cardiovasc Imaging. 2025 Aug;18(8):867-881. doi: 10.1016\u002Fj.jcmg.2025.04.007. Epub 2025 Jul 3.",{"pmid":113,"type":95,"citation":114},"25652181","Habibi M, Lima JA, Khurram IM, Zimmerman SL, Zipunnikov V, Fukumoto K, Spragg D, Ashikaga H, Rickard J, Marine JE, Calkins H, Nazarian S. Association of left atrial function and left atrial enhancement in patients with atrial fibrillation: cardiac magnetic resonance study. Circ Cardiovasc Imaging. 2015 Feb;8(2):e002769. doi: 10.1161\u002FCIRCIMAGING.114.002769.",{"pmid":116,"type":95,"citation":117},"26216085","Goldberger JJ, Arora R, Green D, Greenland P, Lee DC, Lloyd-Jones DM, Markl M, Ng J, Shah SJ. Evaluating the Atrial Myopathy Underlying Atrial Fibrillation: Identifying the Arrhythmogenic and Thrombogenic Substrate. Circulation. 2015 Jul 28;132(4):278-91. doi: 10.1161\u002FCIRCULATIONAHA.115.016795.",{"pmid":119,"type":95,"citation":120},"38324415","Kamel H, Longstreth WT Jr, Tirschwell DL, Kronmal RA, Marshall RS, Broderick JP, Aragon Garcia R, Plummer P, Sabagha N, Pauls Q, Cassarly C, Dillon CR, Di Tullio MR, Hod EA, Soliman EZ, Gladstone DJ, Healey JS, Sharma M, Chaturvedi S, Janis LS, Krishnaiah B, Nahab F, Kasner SE, Stanton RJ, Kleindorfer DO, Starr M, Winder TR, Clark WM, Miller BR, Elkind MSV; ARCADIA Investigators. Apixaban to Prevent Recurrence After Cryptogenic Stroke in Patients With Atrial Cardiopathy: The ARCADIA Randomized Clinical Trial. JAMA. 2024 Feb 20;331(7):573-581. doi: 10.1001\u002Fjama.2023.27188.",{"pmid":122,"type":95,"citation":123},"34024117","Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association\u002FAmerican Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161\u002FSTR.0000000000000375. Epub 2021 May 24. No abstract available.",[],{"nct_id":4,"conditions":126,"biomarkers":129},[127,22,128],"Cryptogenic stroke","Ischemic Stroke",[],{"nct_id":4,"found":131,"summary":132,"prompt_version":142},true,{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is an observational study planning to include 900 participants. It will look back at existing medical information.","completed","Understanding Cryptogenic Stroke and Left Atrial Strain","This study is looking at cryptogenic stroke, a type of stroke where the cause of the blood clot isn't clear. Many people with this type of stroke are at risk for another one. Doctors often recommend blood thinners if an irregular heart rhythm called atrial fibrillation (AF) is found. However, AF can be silent and hard to detect. This study will examine how the left atrium (the heart's upper chamber) functions, specifically looking at something called left atrial strain. When the left atrium doesn't contract normally, blood flow can slow, increasing the risk of clots. Researchers hope to find a link between impaired left atrial strain and cryptogenic stroke, which could help doctors better understand and treat this condition. You may be able to join if you are an adult patient (18-80 years old) who has had a complete heart ultrasound (echocardiography) at UPMC Presbyterian for suspected stroke and have a confirmed stroke diagnosis.","The study will look at the correlation between left atrial strain and cryptogenic stroke at baseline (the start of the study). It is not specified if there is follow-up after this.",154,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]