Skip to content

Diagnostic Yield of Cardiac CT to Detect Cardiac Thrombi in Acute Ischemic Stroke: an Individual Patient Data Meta-Analysis

Diagnostic Yield of Cardiac CT to Detect Cardiac Thrombi in Acute Ischemic Stroke: an Individual Patient Data Meta-Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07165093
Acronym
AIS of HEARTS
Enrollment
3940
Registered
2025-09-10
Start date
2018-05-19
Completion date
2025-09-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac CT, Cardioembolic Stroke, Ischemic Stroke, Thrombus

Keywords

cardiac CT, ischemic stroke, cardioembolic stroke, cardioembolic sources, cardiac thrombus, imaging

Brief summary

The aim of the AIS of HEARTS registry is to establish a database to collect, maintain and provide accessible individual patient data from international cohorts and to provide pooled analyses about the yield and value of cardiac computed tomography (CT), acquired during the initial stroke imaging protocol. The main analysis will investigate the diagnostic yield of cardiac CT to detect cardioembolic sources of stroke in acute ischemic stroke patients.

Detailed description

This study is an individual patient data meta-analysis of four different cohorts (4 hospitals) with both prospective and retrospective data. Patients are included if they underwent cardiac CT (ECG gated or non-ECG gated) acquired during the acute stroke scan protocol. The main paper will focus on the diagnostic yield of cardiac thrombi detected on cardiac CT acquired during the acute stroke scan protocol, the comparison with echocardiography and the 90 day follow-up outcomes. Prospectively planned subanalyses from the AIS of HEARTS registry: Beyond the analyses focussed on cardiac thrombi, the investigators have prespecified the following analyses: * Risk stratification of cardioembolic sources in acute ischemic stroke to improve decision making in performing a cardiac CT * Short term clinical implications of cardiac thrombi detected on cardiac CT * Long term clinical implications of cardiac thrombi detected on cardiac CT * Diagnostic yield of ECG-gated versus non-ECG-gated cardiac CT in the acute phase of ischemic stroke * Association between left atrial appendage contrast filling characteristics and recurrent stroke * Association between left atrial appendage (LAA) morphology/volume and LAA thrombus * Cardiac thrombus and associations with medium vessel occlusions strokes * High-risk cardioembolic sources on cardiac CT in TIA patients * Clinical relevance of valvular vegetations detected on cardiac CT * Long term clinical implications of left atrial diverticula detected on cardiac CT * Incidental findings on cardiac CT The investigators are planning to perform these additional analyses once the main paper has been accepted/submitted.

Interventions

None listed

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Clinical diagnosis of acute ischemic stroke * Cardiac CT acquired during acute stroke scan protocol

Exclusion criteria

* Transient ischemic attack * Stroke mimics

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with cardiac thrombus detected on acute cardiac CT.Baseline: the assessment of a cardiac thrombus is performed when the patient arrives at the Emergency Department and undergoes the acute stroke imaging protocol including a cardiac CT.The proportion of patients with acute ischemic stroke that have a cardiac thrombus detected on cardiac CT.

Secondary

MeasureTime frameDescription
Comparison between cardiac CT and echocardiography for the detection of cardiac thrombi.An average of within 1 year: the investigators include echocardiography that is performed in routine stroke clinical care. This means that the time delay is dependent on various aspect of the local center.Proportion of acute ischemic stroke patients with a cardiac thrombus on cardiac CT and echocardiography, in patients that underwent both investigations.
Follow up 90 days: mortality compared between patients with and without thrombusFrom stroke onset until 90 days follow-upProportion of patients that died at 90 days follow-up after stroke onset.
Follow-up 90 days: recurrent strokeStroke onset until 90 days follow-upProportion of patients that had a recurrent stroke at 90 days follow-up after stroke onset. A recurrent stroke needs to be clearly defined, based on clinical, imaging and other diagnostic information
Follow-up 90 days: outcome using modified rankin scale scoreStroke onset until 90 days follow-upFunctional outcome at 90 days, measured using the modified rankin scale (mRS) score. The mRS score is a scale from 0-6. Higher scores mean a worse functional outcome.

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORJonathan Coutinho, MD, PhD

Amsterdam UMC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026