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Cryptogenic StrokeCASPRNCT06398366

Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence

An observational study of Cryptogenic Stroke, run by Cooper Norcross Health at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is a multi-center retrospective analysis of consecutive adult patients with cryptogenic stroke patients following a comprehensive workup for the underlying stroke etiology. Patients will be eligible for inclusion if the index stroke event occurred between 1/1/2016 and 06/30/2022. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cryptogenic Stroke
How many people
2,000 participants
Where
1 siteUnited States
Study dates
14 Sep 2022to 31 Dec 2026
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: Consecutive adult patients (18 yrs of age or older) diagnosed with cryptogenic stroke despite complete neurodiagnostic workup. Patients admitted between 1/1/2016 and 6/30/2022 with acute ischemic stroke will be screened for inclusion.

Who may be able to join

  • Consecutive adult patients (18 yrs of age or older) diagnosed with cryptogenic stroke despite complete neurodiagnostic workup, including the following:
  • Transthoracic echocardiogram B. EKG and 24h minimum cardiac telemetry C. Cervical and intracranial vessel imaging D. No known and established source of cerebral embolism after completion of the aforementioned testing E. CT or MRI evidence of acute cerebral infarction F. Onset of stroke or last known well within 2 weeks of hospitalization or study inclusion start date (unless time last known well is unknown)
  • Left ventricular ejection fraction greater than or equal to 20%

Who cannot join

  • Patients with an established stroke mechanism that is diagnosed prior to or at the time of the index stroke event. Examples include but are not limited to:
  • New diagnosis of atrial fibrillation during index stroke admission, or history of prior atrial fibrillation B. Cervical or intracranial atherosclerosis in a vessel supplying the infarcted brain region, with 50% luminal stenosis by NASCET criteria C. Cervical or intracranial arterial dissection D. Inflammatory vasculopathy (e.g., giant cell arteritis, primary central nervous system angiitis) E. Acute myocardial infarction or cardiac arrest at the time of stroke F. Intracardiac thrombus (e.g., left ventricular, left atrial, left atrial appendage thrombus), irrespective of cardiac function G. Small vessel disease (defined by the presence of a single, subcortical infarction less than 1.5cm in diameter on computed tomography, less than 2.0cm in diameter on diffusion-weighted imaging, or without radiographic evidence of infarction BUT with symptoms consistent with a subcortical syndrome-e.g., pure motor hemiparesis, pure hemisensory impairment, mixed motor-sensory syndrome, ataxic hemiparesis, or dysarthria-clumsy hand syndrome)
  • Patients without follow-up information at 30 days (although patients who expired within 90 days of stroke are still eligible for inclusion)
  • Patients enrolled in a randomized clinical trial in which antithrombotic group is blinded to the investigator
  • Transient ischemic attack
  • Primary intracerebral hemorrhage

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
  • Cooper Health System

    Camden, New Jersey, 08013

Other trials in United States

About this study

Official title: Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence (CASPR): a Multi-center Observational Cohort Study

This is a multi-center retrospective analysis of consecutive adult patients with cryptogenic stroke patients following a comprehensive workup for the underlying stroke etiology. Patients will be eligible for inclusion if the index stroke event occurred between 1/1/2016 and 06/30/2022.

Read the detailed description

This is an exploratory observational cohort study of existing registry-based clinical, laboratory, and radiographic data. There are multiple pre-specified hypotheses that will be tested using this data set, which include the entire cohort as well as planned subgroup analyses. The analyses center around patients with cryptogenic stroke (no clear stroke mechanism) but who are characterized by "potential embolic sources". These include but are not limited to: left atrial enlargement or dysfunction, left ventricular dysfunction /heart failure with reduced ejection fraction (HFrEF), patent foramen ovale (PFO), paroxysmal atrial fibrillation (pAF), lambl's excrescence, valvular lesions, carotid web, and nonstenotic cervical arterial plaque. A brief summary of several planned hypothesis is itemized below:

  1. To evaluate treatment practices in patients with potential embolic sources.
  2. To estimate the risk of recurrent stroke, major bleeding, and/or death following an incident stroke event across various potential embolic sources.
  3. To compare rates of recurrent stroke, major bleeding, and/or death across various potential embolic sources, when stratified by antithrombotic treatment type.
  4. To evaluate type, frequency, and findings of long-term outpatient cardiac event monitoring (for paroxysmal atrial fibrillation). And furthermore, to determine antithrombotic treatment changes following abnormalities detected with such monitoring.
  5. To develop and validate a risk prediction model for later atrial fibrillation in cryptogenic stroke by integrating a machine-learning algorithm or convolutional neural network analysis of 12-lead electrocardiographic data with clinical, laboratory, and radiographic parameters.
  6. To develop and validate a risk prediction model for later atrial fibrillation, atrial fibrillation burden, and recurrent stroke and/or death using a machine-learning and/or convolutional neural network and/or validated electrophysiologic biomarkers (e.g., p-wave morphology) abstracted from outpatient telemetry, when added to clinical and radiological patient profiles.
  7. To compare the sensitivity of various outpatient cardiac telemetry devices for identifying atrial fibrillation.
  8. To evaluate real-world treatment practices of patent foramen ovale closure, antithrombotic therapy in patent foramen ovale, and risk of stroke recurrence.
  9. To evaluate real-world secondary stroke prevention strategies in patients with heart failure, with and without left ventricular dysfunction.
Keywords
carotid atherosclerosis, heart failure, cardiomyopathy, embolic stroke
Medical subject headings
Ischemic Stroke, Carotid Artery Diseases, Heart Failure, Cardiomyopathies, Embolic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06398366
Study groupRoleWhat they receive
Cooper Health SystemPatients from Cooper Health System and additional sites

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of potential embolic sources

    Epidemiological estimates of prevalence of various potential embolic sources in the cryptogenic stroke population will be calculated across the cohort

    Measured: through study completion, an average of 2 years

  2. The odds of recurrent stroke, major bleeding (according to the International Society of Thrombosis and Hemostasis), and/or death will be estimated across the cohort, with annualized event rates also calculated

    . This outcome will be evaluated across each subgroup of potential embolic source (e.g., valvular lesions present vs. absent, nonstenotic carotid plaque present or absent). Adjusted estimates of event probability will be calculated between patients treated with various antithrombotic types (or class, e.g. anticoagulant vs. antiplatelet) using propensity score matching according to propensity of antithrombotic use

    Measured: At any point during follow-up over a minimum of 90 days after stroke (average of 2 years)

  3. Number of patients treated with antiplatelet, anticoagulant, or combination antithrombotic therapy

    Following the index cryptogenic stroke, the outcome of specific antithrombotic treatment will be compared between patient groups (antiplatelet, anticoagulant, combination antithrombotic)

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start14 Sep 2022
  3. Primary completion30 May 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06398366
Sponsor's protocol ID
22-165
Acronym
CASPR
Status last verified
Jan 2025
First submitted
14 Dec 2023
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khan F, Stretz C, Lewis S, Chahien D, Goldstein E, Siegler JE, Lineback CM, Eklund K, Khasiyev F, Al Kasab S, Culbertson CJ, D'Souza M, Stamm B, Ro J, Kerrigan D, Sharma R, Aboul-Nour H, Nahab F, Omran SS, Linares G, Sehgal S, Melkumova E, Singh E, Zha AM, Thottempudi N, Mannion S, Van Coevering R, Chen L, Thompson SL, Thon JM, Penckofer M, Yu W, Qdais AA, Jillella D, Sloane KL, Dumitrascu OM, Conyers FG, Talat F, Glover PA, Kang J, Patel V, Aziz Y, Zubair A, de Havenon A, Porto CV, Bowman A, Shahrivari M, Brorson JR, Liebeskind DS, Nedelcu S, Ali H, Abdalwahab A, Kam W, Nguyen TN, Herpich F, Farroqui M, Rojas-Soto D, Yaghi S. Comprehensive Diagnostic Evaluation and Risk of Recurrent Stroke After Embolic Stroke of Undetermined Source: Introducing the Concept of ESUS 2.0. J Am Heart Assoc. 2026 Sep 9:e050182. doi: 10.1161/JAHA.126.050182. Online ahead of print.

    PubMed 42714434
  • Aboul-Nour H, Siegler JE, Thompson SL, Glover PA, Daniel JA, Penckofer M, Smith MM, Yaghi S, Ro J, Chen L, D'Souza M, Khasiyev F, Kerrigan D, Sharma R, Aziz YN, Kirchhoffer K, Kam W, Melkumova E, Sloane KL, Lineback CM, Thottempudi N, Heaton S, Linares G, Singh E, Almallouhi E, Stretz C, Albert Fernandez CJ, Dumitrascu OM, Culbertson CJ, Elangovan C, Bowman A, Valhuerdi Porto C, Chahien D, Herpich F, Farooqui M, Kang J, de Havenon A, Nelson A, Shahrivari M, Stamm B, Khezri N, Lewis S, Sathya A, Leung LY, Eklund K, Rojas-Soto D, Nedelcu S, Al Kasab S, Van Coevering RJ, Thon J, Jillella DV, Nahab FB. Real-World Practice in Secondary Stroke Prevention Following Embolic Stroke of Undetermined Source: Secondary Analysis of the CASPR Registry. Neurol Clin Pract. 2026 Aug;16(4):e200631. doi: 10.1212/CPJ.0000000000200631. Epub 2026 Jul 10.

    PubMed 42430672
  • Sharma R, McNamara KF, Badillo Goicoechea E, Bowman A, Van Coevering R, Chen L, Penckofer M, Singh E, Kerrigan D, Aboul-Nour H, Nahab F, Glover P, Krishnaiah B, Yaghi S, Khasiyev F, Lineback CM, Melkumova E, Culbertson C, Nguyen TN, Thompson SL, Jillella D, Daniel JA, Aziz Y, Alvi M, Herpich F, Shahrivari M, Chionatos RA, Elangovan C, Kang J, Zha A, Farooqui M, Rothstein A, Khan F, Smith M, Brown SJ, Abu Qdais A, Liebeskind DS, Abburi N, Rozental S, Nedelcu S, Thon JM, Stretz C, Thottempudi N, Yu W, Eklund K, Linares G, de Havenon A, Siegler JE. Recurrent Stroke in Patients With Cryptogenic Stroke and Left Ventricular Injury: The Cardiac Abnormalities in Stroke Prevention and Recurrence (CASPR) Study. Stroke. 2026 May;57(5):1175-1186. doi: 10.1161/STROKEAHA.125.053755. Epub 2026 Mar 2.

    PubMed 41766531
  • Siegler JE, Goicoechea EB, Penckofer M, Eklund K, Yaghi S, Stretz C, Lineback CM, Stamm B, Peter S, D'Souza M, Conyers FG, Khasiyev F, Kerrigan D, Lewis S, Ali H, Aboul-Nour H, Sharma R, Nahab FB, Glover P, Thompson SL, Alshaer QN, Thottempudi N, de Havenon A, Culbertson CJ, Melkumova E, Chionatos RA, Jillella DV, Daniel JA, Ro J, Frankel MR, Dumitrascu OM, Brown S, Parikh P, Doolittle C, Yahnke I, Sathya A, Kang J, Kirchhoffer K, Bowman A, Smith MM, Brorson JR, Asabere A, Shahrivari M, Elangovan C, Sheibani N, Krishnaiah B, Gaudio E, Sloane KL, Rothstein A, Alvi MM, Annam S, Amankwah C, Kam W, Abburi N, Farooqui M, Rojas-Soto D, Molaie A, Khezri N, Zubair AS, Abbasi M, Van Coevering RJ, Chen L, Nedelcu S, Herpich F, Chahien D, Sehgal S, Liebeskind DS, Linares G, Zha A, Sarkar M, Xi R, Nelson A, Abu Qdais A, Al Kasab S, Singh E, Patel V, Aziz YN, Mehndiratta P, DeMarco A, Sharrief A, Cucchiara B, Salehi Omran S, Nguyen TN, Dubinski M, Ackerman J, Thon J. Outcomes of Patients With Embolic Stroke of Undetermined Source Treated With Antiplatelet Agents or Anticoagulation: A Multicenter Cohort Study. Neurology. 2025 Aug 12;105(3):e213876. doi: 10.1212/WNL.0000000000213876. Epub 2025 Jul 3.

    PubMed 40609061

Questions about this trial

What is this clinical trial studying?

An observational study of Cryptogenic Stroke, run by Cooper Norcross Health 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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 23 Jan 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of potential embolic sources (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. 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 NCT06398366, which also lists 4 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 23 Jan 2025.

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