NCT07165093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
Last Updated

January 21, 2026

Status Verified

August 1, 2025

Enrollment Period

6.1 years

First QC Date

August 9, 2025

Last Update Submit

January 17, 2026

Conditions

Keywords

cardiac CTischemic strokecardioembolic strokecardioembolic sourcescardiac thrombusimaging

Outcome Measures

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.

    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.

    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

    From stroke onset until 90 days follow-up

  • Follow-up 90 days: recurrent stroke

    Stroke onset until 90 days follow-up

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

    Stroke onset until 90 days follow-up

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Transient ischemic attack
  • Stroke mimics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Ischemic StrokeEmbolic StrokeThrombosis

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Study Officials

  • Jonathan Coutinho, MD, PhD

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2025

First Posted

September 10, 2025

Study Start

May 19, 2018

Primary Completion

June 30, 2024

Study Completion

September 1, 2025

Last Updated

January 21, 2026

Record last verified: 2025-08

Locations