Ischemic Stroke, CryptogenicLAS-ESUSNCT07224178
Left Atrial Strain and Cryptogenic Stroke
An observational study of Ischemic Stroke, Cryptogenic and Ischemic Stroke, Embolic, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Cryptogenic, Ischemic Stroke, Embolic, Hemorrhagic Stroke
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from adult patients evaluated for stroke at the University of Pittsburgh Medical Center (UPMC) and collaborating university hospitals that serve as tertiary care centers with established cardiovascular imaging programs. Only subjects who have already undergone transthoracic echocardiography as part of their stroke workup, and who have clinical and imaging data available for retrospective analysis will be included. The UPMC will provide both the data collection platform -REDCap- and Echocardiography Core Laboratory for centralized image analysis.
Who may be able to join
- Adult patients (age > 18 years and < 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.
- 2- Patients with an established diagnosis of stroke by stroke neurologists.
- 3- Patients in sinus rhythm documented at the time of referral.
- 4- Availability of adequate echocardiographic images for strain quantification.
- 5- Clinical follow-up data available for evaluation of study endpoints, including stroke recurrence, atrial fibrillation development, and mortality.
- 6- Patients from collaborating centers will be included with de-identified echocardiographic images and clinical data meeting the above criteria.
Who cannot join
- Incomplete or technically difficult transthoracic echocardiography (TTE) studies and studies from subjects younger than 18 years of age will be excluded. Additional exclusion criteria include:
- 1- 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.
- 2 -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.
- 3- Coagulopathy: Patient having disease leading to hypercoagulable (thrombus formation) state will be excluded (presence of cancer, antiphospholipid antibodies, hematological diseases).
- 4- 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.
- 5- Poor image quality for strain analysis: Patients having echo exams with inadequate image quality that prevent reliable strain quantification will be excluded.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Leyla E Sade, MD, 412-215-3464, sadele2@upmc.edu
Benay Ozbay, MD, 412-450-2774, ozbayb@upmc.edu
About this study
Official title: Left Atrial Strain: A Biomarker for Cryptogenic Stroke Prevention
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.
AF 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.
This 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.
Read the detailed description
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.
This 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.
By 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.
- Conditions
- Ischemic Stroke, Cryptogenic, Ischemic Stroke, Embolic, Hemorrhagic Stroke, Embolic Stroke of Undetermined Source, Recurrent Ischemic Stroke
- Keywords
- stroke, embolic stroke of undetermined source, speckle-tracking echocardiography, left atrial cardiomyopathy, left atrial strain, recurrent ischemic stroke, new-onset atrial fibrillation
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cryptogenic Stroke Cohort | Subjects in sinus rhythm who had a diagnosis of ischemic embolic stroke in whom no clear embolic source was identified after standard diagnostic evaluation (TOAST classification: Embolic Stroke of Undetermined Source) and who had transthoracic echocardiography (TTE) as part of the stroke work up will constitute the first group. | |
| Non-Cryptogenic Stroke Cohort (Comparator Group) | Subjects in sinus rhythm who had a non-cryptogenic stroke (e.g., large artery atherosclerosis, small vessel disease, hemorrhagic) and who underwent transthoracic echocardiography as part of the clinical stroke workup. This group will serve as a comparator for the primary analysis to determine whether LA strain determines cryptogenic stroke among other stroke subtypes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Up to 1 year from date of index transthoracic echocardiography.
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.
Measured: Up to 1 year from date of index transthoracic echocardiography.
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.
Measured: Up to 1 year from date of index transthoracic echocardiography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start17 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, CryptogenicStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Sade, University of Pittsburgh
- Investigators
- Leyla E Sade, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224178
- Sponsor's protocol ID
- STUDY25010088
- Acronym
- LAS-ESUS
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected in this study, including baseline characteristics, clinical outcomes, and left atrial strain measurements, will be shared. Data will be available upon reasonable request for researchers conducting methodologically sound studies that align with the objectives of this research.
Publications
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/M22-1638. Epub 2022 Dec 20.
PubMed 36534978Masini 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/STROKEAHA.124.047747. Epub 2025 Mar 7.
PubMed 40052267Sade 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/ehjci/jeaa311.
PubMed 33206942Sade 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/ehjci/jeaf014.
PubMed 39812172Clark 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/eci.14175. Epub 2024 Feb 2.
PubMed 38308431Ozbay 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/j.jcmg.2025.04.007. Epub 2025 Jul 3.
PubMed 40608042Habibi 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/CIRCIMAGING.114.002769.
PubMed 25652181Goldberger 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/CIRCULATIONAHA.115.016795.
PubMed 26216085Kamel 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/jama.2023.27188.
PubMed 38324415Kleindorfer 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/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Strain: A Biomarker for Cryptogenic Stroke Prevention
- ClinicalTrials.gov ID
- NCT07224178
- Acronym / sponsor ID
- LAS-ESUS / STUDY25010088
- Conditions
- Ischemic Stroke, Cryptogenic, Ischemic Stroke, Embolic, Hemorrhagic Stroke, Embolic Stroke of Undetermined Source, Recurrent Ischemic Stroke
- Keywords
- stroke, embolic stroke of undetermined source, speckle-tracking echocardiography, left atrial cardiomyopathy, left atrial strain, recurrent ischemic stroke, new-onset atrial fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
AF 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.
This 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.
Detailed description
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.
This 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.
By 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryptogenic Stroke Cohort | – | –Subjects in sinus rhythm who had a diagnosis of ischemic embolic stroke in whom no clear embolic source was identified after standard diagnostic evaluation (TOAST classification: Embolic Stroke of Undetermined Source) and who had transthoracic echocardiography (TTE) as part of the stroke work up will constitute the first group. |
| Non-Cryptogenic Stroke Cohort (Comparator Group) | – | –Subjects in sinus rhythm who had a non-cryptogenic stroke (e.g., large artery atherosclerosis, small vessel disease, hemorrhagic) and who underwent transthoracic echocardiography as part of the clinical stroke workup. This group will serve as a comparator for the primary analysis to determine whether LA strain determines cryptogenic stroke among other stroke subtypes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from adult patients evaluated for stroke at the University of Pittsburgh Medical Center (UPMC) and collaborating university hospitals that serve as tertiary care centers with established cardiovascular imaging programs. Only subjects who have already undergone transthoracic echocardiography as part of their stroke workup, and who have clinical and imaging data available for retrospective analysis will be included. The UPMC will provide both the data collection platform -REDCap- and Echocardiography Core Laboratory for centralized image analysis.
Key inclusion criteria (6 listed)
- Adult patients (age > 18 years and < 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.
- 2- Patients with an established diagnosis of stroke by stroke neurologists.
- 3- Patients in sinus rhythm documented at the time of referral.
- 4- Availability of adequate echocardiographic images for strain quantification.
- 5- Clinical follow-up data available for evaluation of study endpoints, including stroke recurrence, atrial fibrillation development, and mortality.
Key exclusion criteria (7 listed)
- Incomplete or technically difficult transthoracic echocardiography (TTE) studies and studies from subjects younger than 18 years of age will be excluded. Additional exclusion criteria include:
- 1- 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.
- 2 -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.
- 3- Coagulopathy: Patient having disease leading to hypercoagulable (thrombus formation) state will be excluded (presence of cancer, antiphospholipid antibodies, hematological diseases).
- 4- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between left atrial strain (percent deformation) and the rate of cryptogenic stroke
Time frame: Baseline
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.
3 secondary outcomes
Prediction of recurrent cryptogenic stroke by left atrial strain (percent deformation)
Time frame: Up to 1 year from date of index transthoracic echocardiography.
Incidence of cardiovascular and cerebrovascular mortality among patients with impaired LA strain (percent deformation)
Time frame: Up to 1 year from date of index transthoracic echocardiography.
Incidence of newly detected atrial fibrillation among patients with impaired LA strain
Time frame: Up to 1 year from date of index transthoracic echocardiography.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 36534978Maheshwari 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/M22-1638. Epub 2022 Dec 20.
- Background: PubMed 40052267Masini 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/STROKEAHA.124.047747. Epub 2025 Mar 7.
- Background: PubMed 33206942Sade 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/ehjci/jeaa311.
- Background: PubMed 39812172Sade 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/ehjci/jeaf014.
- Background: PubMed 38308431Clark 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/eci.14175. Epub 2024 Feb 2.
- Background: PubMed 40608042Ozbay 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/j.jcmg.2025.04.007. Epub 2025 Jul 3.
- Background: PubMed 25652181Habibi 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/CIRCIMAGING.114.002769.
- Background: PubMed 26216085Goldberger 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/CIRCULATIONAHA.115.016795.
- Background: PubMed 38324415Kamel 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/jama.2023.27188.
- Background: PubMed 34024117Kleindorfer 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/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected in this study, including baseline characteristics, clinical outcomes, and left atrial strain measurements, will be shared. Data will be available upon reasonable request for researchers conducting methodologically sound studies that align with the objectives of this research.
Related trials for Ischemic Stroke, Cryptogenic
RecruitingPhase 4
NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke
Stroke, Stroke, Acute Ischemic
Recruiting
Intensive Cancer Screening After Cryptogenic Stroke
Occult Cancer
Recruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Patent Foramen Ovale, Stroke
Active, not recruitingPhase 3
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
Patent Foramen Ovale, Atrial Arrhythmia
Recruiting
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
PFO, PFO - Patent Foramen Ovale
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leyla E Sade, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Cryptogenic and Ischemic Stroke, Embolic, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leyla E Sade, MD (412-215-3464, sadele2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between left atrial strain (percent deformation) and the rate of cryptogenic stroke (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07224178, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.