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

NCT ID: NCT07165093

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3940 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-19
• Study Completion Date: 2025-09-01

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.

Conditions

Ischemic Stroke; Cardioembolic Stroke; Thrombus; Cardiac CT

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Amsterdam UMC

Patients from Amsterdam UMC that underwent ECG-gated cardiac CT

No interventions assigned to this group

Christchurch Hospital

Patients from Christchurch hospital that underwent non-ECG gated cardiac CT

No interventions assigned to this group

John Hunter Hospital

Patients from John Hunter Hospital that underwent non-ECG gated cardiac CT

No interventions assigned to this group

Liverpool Hospital

Patients from Liverpool Hospital that underwent ECG-gated cardiac CT

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Coutinho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Coutinho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Amsterdam UMC

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL64139.018.18

Identifier Type: -

Identifier Source: org_study_id