Left Atrial Strain and Cryptogenic Stroke

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

900 Participants
are grouped into 2 trial groups
Group A: Cryptogenic Stroke Cohort
Group B: Non-Cryptogenic Stroke Cohort (Comparator Group)

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Up to 1 year from date of index transthoracic echocardiography.
2

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.

Time frame
Up to 1 year from date of index transthoracic echocardiography.
3

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.

Time frame
Up to 1 year from date of index transthoracic echocardiography.

Other outcomes

Sponsors and contacts

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