Skip to main content
OpenTrials
Completed

NCT Number: NCT07165093

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiac CT Cardioembolic Stroke Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolic Stroke Embolism and Thrombosis Nervous System Diseases Stroke Thrombosis Thrombus Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of patients with cardiac thrombus detected on acute cardiac CT.

    Time frame: 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 outcomes

  1. Comparison between cardiac CT and echocardiography for the detection of cardiac thrombi.

    Time frame: 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.

  2. Follow up 90 days: mortality compared between patients with and without thrombus

    Time frame: From stroke onset until 90 days follow-up

    Proportion of patients that died at 90 days follow-up after stroke onset.

  3. Follow-up 90 days: recurrent stroke

    Time frame: Stroke onset until 90 days follow-up

    Proportion 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

  4. Follow-up 90 days: outcome using modified rankin scale score

    Time frame: Stroke onset until 90 days follow-up

    Functional 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: AIS of HEARTS

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.