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CompletedNCT07165093AIS of HEARTSUpdated Jan 21, 2026

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

An observational study in Ischemic Stroke, Cardioembolic Stroke and Thrombus, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Primary conditionEmbolic StrokeRegistry: Ischemic StrokeReclassifiedWhy we changed it
Registry
Ischemic Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Embolic Stroke
Why
  1. The study's listed conditions name Embolic Stroke, a narrower term within Ischemic Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
3,940
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Ischemic Stroke
  • Cardioembolic Stroke
  • Thrombus
  • Cardiac CT

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Keywords

  • cardiac CT
  • ischemic stroke
  • cardioembolic stroke
  • cardioembolic sources
  • cardiac thrombus
  • imaging
03

In context

Embolic Stroke Reclassified

40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.

This study's enrollment of 3,940 is above the median of 364 across 27 observational studies indexed under Embolic Stroke.

Browse Embolic Stroke studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.

Compared within Embolic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ischemic Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients 18 years or older with acute ischemic stroke that underwent a cardiac CT during the acute stroke scanprotocol.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Stroke mimics
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
3,940 participants (actual)
Patient registry
No

Groups and cohorts

  • Amsterdam UMC

    Patients from Amsterdam UMC that underwent ECG-gated cardiac CT

  • Christchurch Hospital

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

  • John Hunter Hospital

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

  • Liverpool Hospital

    Patients from Liverpool Hospital that underwent ECG-gated cardiac CT

06

What researchers measure

Primary outcomes

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

    The proportion of patients with acute ischemic stroke that have a cardiac thrombus detected on 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.

Secondary outcomes

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

    Proportion of acute ischemic stroke patients with a cardiac thrombus on cardiac CT and echocardiography, in patients that underwent both investigations.

    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.

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

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

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

  3. Follow-up 90 days: recurrent stroke

    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

    Time frame: Stroke onset until 90 days follow-up

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

    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.

    Time frame: Stroke onset until 90 days follow-up

07

Study locations

1 site
  • Amsterdam UMC
    Amsterdam, 1105 AZ, Netherlands
08

References and documents

Publications

  • Nio SS, Green DS, Berry-Noronha A, Rinkel LA, Beemsterboer CFP, Hasnain MG, Planken RN, van Randen A, Al-Hadethi S, Hilt MGM, Ruhe DSA, Bouma BJ, Boekholdt SM, Chew BLA, Fridgant J, Mena-Romo L, Kim DH, Guo S, Alamri Y, Winders J, Senadeera SC, Lim AT, Fink JN, Leung M, Cordato D, Parsons MW, Spratt NJ, Garcia-Esperon C, Wu TY, Coutinho JM; AIS of HEARTS Collaborators. Diagnostic Yield of Cardiac CT to Detect Cardiac Thrombi in Patients With Acute Ischemic Stroke (AIS of HEARTS). Stroke. 2026 Jun 2;57(8):2408-16. doi: 10.1161/STROKEAHA.126.055575. Online ahead of print. PubMed 42227105 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07165093
Responsible party
Jonathan Coutinho (Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Sep 10, 2025
Start date
May 19, 2018
Primary completion
Jun 30, 2024
Completion
Sep 1, 2025
Last update
Jan 21, 2026

Study contacts

Jonathan Coutinho, MD, PhD
principal investigator · Amsterdam UMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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