Ischemic StrokeAIS of HEARTSNCT07165093
Diagnostic Yield of Cardiac CT to Detect Cardiac Thrombi in Acute Ischemic Stroke: an Individual Patient Data Meta-Analysis
An observational study of Ischemic Stroke and Cardioembolic Stroke, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Cardioembolic Stroke, Thrombus
- How many people
- 3,940 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 May 2018to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or older with acute ischemic stroke that underwent a cardiac CT during the acute stroke scanprotocol.
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of acute ischemic stroke
- Cardiac CT acquired during acute stroke scan protocol
Who cannot join
- Transient ischemic attack
- Stroke mimics
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ischemic Stroke, Cardioembolic Stroke, Thrombus, Cardiac CT
- Keywords
- cardiac CT, ischemic stroke, cardioembolic stroke, cardioembolic sources, cardiac thrombus, imaging
- Medical subject headings
- Ischemic Stroke, Embolic Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: 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.
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.
Measured: From stroke onset until 90 days follow-up
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
Measured: Stroke onset until 90 days follow-up
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.
Measured: Stroke onset until 90 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start19 May 2018
- Primary completion30 Jun 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,940 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Coutinho, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jonathan Coutinho, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165093
- Sponsor's protocol ID
- NL64139.018.18
- Acronym
- AIS of HEARTS
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Aug;57(8):2408-2416. doi: 10.1161/STROKEAHA.126.055575. Epub 2026 Jun 2.
PubMed 42227105
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Cardiac CT to Detect Cardiac Thrombi in Acute Ischemic Stroke: an Individual Patient Data Meta-Analysis
- ClinicalTrials.gov ID
- NCT07165093
- Acronym / sponsor ID
- AIS of HEARTS / NL64139.018.18
- Conditions
- Ischemic Stroke, Cardioembolic Stroke, Thrombus, Cardiac CT
- Keywords
- cardiac CT, ischemic stroke, cardioembolic stroke, cardioembolic sources, cardiac thrombus, imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,940 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 19 May 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older with acute ischemic stroke that underwent a cardiac CT during the acute stroke scanprotocol.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Clinical diagnosis of acute ischemic stroke
- Cardiac CT acquired during acute stroke scan protocol
Key exclusion criteria (2 listed)
- Transient ischemic attack
- Stroke mimics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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.
Follow up 90 days: mortality compared between patients with and without thrombus
Time frame: From stroke onset until 90 days follow-up
Follow-up 90 days: recurrent stroke
Time frame: Stroke onset until 90 days follow-up
Follow-up 90 days: outcome using modified rankin scale score
Time frame: Stroke onset until 90 days follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42227105Nio 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 Aug;57(8):2408-2416. doi: 10.1161/STROKEAHA.126.055575. Epub 2026 Jun 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Coutinho, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Cardioembolic Stroke, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.