Left atrial function in people with unexplained (cryptogenic) stroke.
Left Atrial Strain: A Biomarker for Cryptogenic Stroke Prevention
This will see if lower left atrial strain on a heart ultrasound is linked to unexplained (cryptogenic) stroke and to higher risk of another stroke in adults who had a stroke without a known cause.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07224178 on ClinicalTrials.gov |
What this trial studies
This multicenter retrospective study analyzes echocardiographic images from adults referred for stroke evaluation to determine whether impaired left atrial (LA) strain is associated with cryptogenic stroke and with recurrent events. Echocardiographic images will be reanalyzed offline using standardized speckle-tracking software and de-identified images and clinical data will be collected in a central core laboratory at the University of Pittsburgh. Clinical follow-up data on recurrent stroke, new atrial fibrillation, and mortality will be used to compare outcomes across LA strain measures. The aim is to validate LA strain as a noninvasive biomarker of atrial cardiopathy that could help explain otherwise unexplained embolic strokes.
Who should consider this trial
Good fit: Adults aged 18–79 who had a complete transthoracic echocardiogram during stroke workup, were in sinus rhythm at the time, have adequate images for strain analysis, and have clinical follow-up data are the ideal candidates.
Not a fit: Patients with poor-quality echocardiographic images, known atrial fibrillation at baseline, strokes with an identified cause, or who were not evaluated at participating centers are unlikely to benefit from these findings.
Why it matters
Potential benefit: If successful, LA strain could help identify patients at higher risk of recurrent cryptogenic stroke and guide closer monitoring or treatment decisions.
How similar studies have performed: Prior studies have suggested links between impaired LA strain and atrial fibrillation or stroke risk, but using LA strain specifically to predict recurrence in cryptogenic stroke is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 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. \-
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Presbyterian — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Leyla E Sade, MD — University of Pittsburgh Medical Center
- Study coordinator: Leyla E Sade, MD
- Email: sadele2@upmc.edu
- Phone: 412-215-3464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.