Detecting Cardiac Thrombi in Acute Ischemic Stroke on Cardiac CT Versus Transoesophageal Echocardiography

NCT06585228 | Recruiting DMC

• 1 other identifier: NL84141.018.23
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Cardiac CT acquired during the acute stroke imaging protocol (acute cardiac CT) has recently been shown to have a superior diagnostic yield than transthoracic echocardiography, which is currently the most commonly used method to screen for structural sources of cardioembolism in patients with acute ischemic stroke. The most common finding on acute cardiac CT are cardiac thrombi located in the left atrium (LA) and specifically the left atrial appendage (LAA). The higher diagnostic yield of acute cardiac CT compared to TTE is partially explained because CT allows for better visualization of the LAA, but also because cardiac thrombi may dissolve in the first days after stroke. Whether acute cardiac CT is the optimal diagnostic modality for LA thrombi in stroke patients is unknown, since data comparing it to transoesophageal echocardiography (TEE), which is the reference standard to detect LA thrombi, are lacking. The general hypothesis of this study is that acute cardiac CT is the optimal method to detect LA thrombi in ischemic stroke patients, since TEE can miss LA thrombi that dissolve in the first days after stroke. Objectives:

1. 1.Determine whether acute cardiac CT has a higher diagnostic probability of detecting LA thrombi compared to TEE or repeated cardiac CT in the subacute phase of ischemic stroke by assessing the rate at which LA thrombi dissolve in the first days after ischemic stroke occurrence.
2. 2.Determine the positive predictive value of acute cardiac CT compared to TEE for the detection of LA thrombi. Study design: Prospective, single-centre, observational cohort Study population: 39 patients of 18 years or older with acute ischemic stroke and a LA thrombus detected on cardiac CT acquired during the acute stroke imaging.
3. 3.Rate at which LA thrombi visualized on acute cardiac CT dissolve in the first days after ischemic stroke.
4. 4.False-positive rate for detection of left atrial thrombi on acute cardiac CT compared to TEE. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Clinical and imaging patient data which are obtained as part of standard care will be prospectively collected after written informed consent. Patient with a LA thrombus on acute cardiac CT will undergo TEE for research purposes after obtaining written informed consent. TEE is semi-invasive and associated with a small risk of major complications (\<0.2%). Patients will also be exposed to additional radiation (1.4 mSV) due to sequential cardiac CT after TEE. The Radiation Dose Committee deemed this to be an intermediate risk. In a small minority of patients (\<10%), another cardiac CT will be acquired 2 minutes after this sequential cardiac CT to ensure a clear, final assessment of the presence of an atrial appendage thrombus. This will result in a total additional radiation of 3 mSV for the two additional cardiac CT's. The Radiation Dose Committee deemed this to be an intermediate risk. As part of standard care, patients will be contacted for follow-up evaluation by a trained stroke nurse at 90 days. As a result of ischemic stroke, some patients become incapacitated to an extent they are unable to give informed consent. In these cases, the legal representative will be asked for informed consent. Decreased leveI of consciousness or aphasia are typical clinical characteristics of cardioembolic stroke. Therefore, it is pivotal to also include incapacitated acute ischemic stroke patients. Excluding these patients from the study would render the study non-representative of the study's target population (acute ischemic stroke patients with cardioembolic stroke due to LA thrombus).

Conditions

Ischemic Stroke; Cardioembolic Stroke; Thrombus; Embolism; Left Atrial Thrombosis; Left Atrial Appendage Thrombosis

Keywords

Cardiac CT; Transoesophageal echocardiography; Ischemic stroke

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with a left atrial thrombus

  The proportion of patients with a LA thrombus detected on acute cardiac CT that dissolves in the first days after stroke, defined as thrombi that are seen on initial cardiac CT but are no longer visible on TEE and repeated cardiac CT.

  The assessment of a left atrial thrombus is performed when the patient arrives at the Emergency Department and undergoes the acute stroke imaging protocol including a cardiac CT.

• Positive predictive value of acute cardiac CT compared to TEE.

  Positive predictive value of acute cardiac CT compared to TEE.

  The assessment of a left atrial thrombus is performed when the patient arrives at the Emergency Department and undergoes the acute stroke imaging protocol including a cardiac CT. The TEE is performed <7 days after the cardiac CT.

Secondary Outcomes (2)

• Other pre-defined high-risk and non-high-risk sources of embolism on cardiac CT and TEE

  Cardiac CT is performed and assessed when the patients arrives at the Emergency Department. The TEE is performed <7 days after the cardiac CT.

• Clinical impact of cardiac thrombi

  The clinical data of patients with a thrombi is collected on arrival at the Emergency Department and follow-up is performed at 90 days and 2 years to assess functional outcome, recurrent stroke and cardiovascular events

Interventions

Cardiac Computed Tomography DIAGNOSTIC_TEST

Cardiac CT acquired during the acute stroke imaging protocol

Also known as: Cardiac CT, CCT

Transesophageal echocardiography DIAGNOSTIC_TEST

Ultrasound through the oesophagus to assess cardiac structures.

Also known as: TEE

Repeated Cardiac Computed Tomography DIAGNOSTIC_TEST

A second cardiac CT performed after the TEE.

Also known as: Cardiac CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older with acute ischemic stroke and a LA thrombus detected on cardiac CT acquired during the initial stroke imaging protocol at Amsterdam UMC, location AMC.

You may qualify if:

• Age 18 years or older
• Clinical diagnosis of acute ischemic stroke
• Written informed consent from patient or representative
• Radiological diagnosis of cardiac thrombus in the LA, including the LAA, on cardiac CT acquired during the initial stroke imaging protocol.

You may not qualify if:

• Patients with a diagnosis other than acute ischemic stroke, such as: transient ischemic attack, intracerebral haemorrhage, subarachnoid haemorrhage, epilepsy, tumor.
• Absolute contraindication for TEE:
• Perforated viscus
• Esophageal stricture
• Esophageal tumor
• Esophageal perforation, laceration
• Esophageal diverticulum
• Active upper GI bleed
• Absolute contraindication for repeat cardiac CT
• Documented previous severe reaction to iodinated contrast media, including anaphylaxis, angioedema and bronchospasm.
• Severely impaired kidney function defined as estimated glomerular filtration rate of 30 mL/min/1.73 m2.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Center (UMC)

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Embolic Stroke; Thromboembolism

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Jonathan M Coutinho, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan Sui Nio, MD

CONTACT

020 5664591; s.nio@amsterdamumc.nl

Jonathan M Coutinho, MD, PhD

CONTACT

0205662004; j.coutinho@amsterdamumc.nl

Study Design

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

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 3, 2025

Record last verified: 2024-09

Locations

NL (1)