Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence

NCT06398366 | Enrolling By Invitation

• 1 other identifier: 22-165
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cryptogenic Stroke

Keywords

carotid atherosclerosis; heart failure; cardiomyopathy; embolic stroke

Outcome Measures

Primary Outcomes (3)

• 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

  through study completion, an average of 2 years

• 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

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

• 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)

  through study completion, an average of 2 years

Study Arms (1)

Cooper Health System

Patients from Cooper Health System and additional sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Consecutive adult patients (18 yrs of age or older) diagnosed with cryptogenic stroke despite complete neurodiagnostic workup, including the following:
• Left ventricular ejection fraction greater than or equal to 20%

You may not qualify if:

• 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:
• A. 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 enrolled in a randomized clinical trial in which antithrombotic group is blinded to the investigator
• Transient ischemic attack
• Primary intracerebral hemorrhage

Sponsors & Collaborators

• The Cooper Health System: lead
• Duke University: collaborator
• Covenant Health, Canada: collaborator
• University of Colorado, Denver: collaborator
• Medical University of South Carolina: collaborator
• University of Maryland, Baltimore: collaborator
• University of Pennsylvania: collaborator
• Emory University: collaborator
• University of Chicago: collaborator
• University of Tennessee: collaborator
• Ohio State University: collaborator
• West Virginia University: collaborator
• Mayo Clinic: collaborator
• Boston Medical Center: collaborator
• Rhode Island Hospital: collaborator
• Beth Israel Lahey Health: collaborator
• Christiana Care Health Services: collaborator
• Henry Ford Health System: collaborator
• Thomas Jefferson University: collaborator
• University of Iowa: collaborator
• University of California, Los Angeles: collaborator
• Allina Health System: collaborator
• Yale University: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (1)

Cooper Health System

Camden, New Jersey, 08013, United States

Location

Related Publications (1)

• 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.

  PMID: 40609061 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Carotid Artery Diseases; Heart Failure; Cardiomyopathies; Embolic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Jesse Thon

  Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: May 3, 2024
• Study Start: September 14, 2022
• Primary Completion: May 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)