Recruiting

LA Strain

Sponsor:

University of Pittsburgh

Code:

NCT07224178

Conditions

Ischemic Stroke, Cryptogenic

Ischemic Stroke, Embolic

Hemorrhagic Stroke

Embolic Stroke of Undetermined Source

Recurrent Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.

Conditions

Ischemic Stroke, Cryptogenic

Ischemic Stroke, Embolic

Hemorrhagic Stroke

Embolic Stroke of Undetermined Source

Recurrent Ischemic Stroke

Study ID

NCT07224178

Start date

Dec 17, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

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Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Correlation between left atrial strain (percent deformation) and the rate of cryptogenic stroke [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Leyla E Sade, MD

412-215-3464sadele2@upmc.edu

Benay Ozbay, MD

412-450-2774ozbayb@upmc.edu

Locations

UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Leyla E Sade, MD

412-215-3464sadele2@upmc.edu

Benay Ozbay, MD

412-450-2774ozbayb@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • stroke
  • embolic stroke of undetermined source
  • speckle-tracking echocardiography
  • left atrial cardiomyopathy
  • left atrial strain
  • recurrent ischemic stroke
  • new-onset atrial fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-01-07.