Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT07165093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Yield of Cardiac CT to Detect Cardiac Thrombi in Acute Ischemic Stroke: an Individual Patient Data Meta-Analysis
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Organization:
Study Overview
Official Title:
Diagnostic Yield of Cardiac CT to Detect Cardiac Thrombi in Acute Ischemic Stroke: an Individual Patient Data Meta-Analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIS of HEARTS
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.
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, we 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 We are planning to perform these additional analyses once the main paper has been accepted/submitted.
Prospectively planned subanalyses from the AIS of HEARTS registry:
Beyond the analyses focussed on cardiac thrombi, we 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 We are planning to perform these additional analyses once the main paper has been accepted/submitted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: