NCT07224178 Left Atrial Strain and Cryptogenic Stroke
| NCT ID | NCT07224178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Ischemic Stroke, Cryptogenic |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2025-12-17 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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. \-
Contact & Investigator
Leyla E Sade, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh Medical Center
Frequently Asked Questions
Who can join the NCT07224178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke, Cryptogenic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07224178 currently recruiting?
Yes, NCT07224178 is actively recruiting participants. Contact the research team at sadele2@upmc.edu for enrollment information.
Where is the NCT07224178 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07224178 clinical trial?
NCT07224178 is sponsored by University of Pittsburgh. The principal investigator is Leyla E Sade, MD at University of Pittsburgh Medical Center. The trial plans to enroll 900 participants.
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