Observational Enrolling by invitation
NCT06398366 on ClinicalTrials.gov
Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence
Official title: Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence (CASPR): a Multi-center Observational Cohort Study
- Sponsor: The Cooper Health System
- Collaborators: Duke University, Covenant Health, University of Colorado, Denver, Medical University of South Carolina, University of Maryland, Baltimore, University of Pennsylvania, Emory University, University of Chicago, University of Tennessee, Ohio State University, West Virginia University, Mayo Clinic, Boston Medical Center, Rhode Island Hospital, Beth Israel Lahey Health, Christiana Care Health Services, Henry Ford Health System, Thomas Jefferson University, University of Iowa, University of California, Los Angeles, Allina Health System, Yale University, The University of Texas Health Science Center, Houston, Dartmouth-Hitchcock Medical Center, Virginia Commonwealth University
- Enrollment: 2000 (Estimated)
- Study start: 2022-09-14 (Actual)
- Primary completion: 2025-05-30 (Estimated)
- Study completion: 2026-12-31 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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
Primary Outcome Measures
-
Prevalence of potential embolic sources
(through study completion, an average of 2 years)
Epidemiological estimates of prevalence of various potential embolic sources in the cryptogenic stroke population will be calculated across the cohort -
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
(At any point during follow-up over a minimum of 90 days after stroke (average of 2 years))
. 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 -
Number of patients treated with antiplatelet, anticoagulant, or combination antithrombotic therapy
(through study completion, an average of 2 years)
Following the index cryptogenic stroke, the outcome of specific antithrombotic treatment will be compared between patient groups (antiplatelet, anticoagulant, combination antithrombotic)
Countries
United States
Locations and Investigators
- Cooper Health System, Camden, United States
Study Officials
- Jesse Thon (Principal Investigator) — Cooper Health System