Cardiac Thrombus in Early Cardiac CT Scan in Etiological Workup of Ischemic Stroke: Prospective Study (CCT STROKE)

August 8, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Stroke can be linked to atherosclerosis of the large vessels, occlusion of the small intracerebral vessels (gaps), cardioembolic pathology or other rarer etiologies.

The cardioembolic etiology of stroke in elderly patients may be difficult to prove. Paroxysmal atrial fibrillation (AF) is a common cause of cerebral infarction (25%). Detecting AF is not easy. A 24-hour long-term holter and an implantable cardiac monitor (Reveal®) may be required. This etiology is all the more important as it requires anticoagulation treatment reducing the risk of recurrence in the short and long term. The left atrium thrombus is an indisputable marker of atrial fibrillation but it is rarely seen. Other cardiac etiologies such as a thrombus in the left ventricle, a large plaque or a thrombus of the aortic arch are possible. Finally, the permeable oval foramen and the aneurysm of the intra-auricular septum constitute a cause apart in young subjects (<60 years).

Typically, the search for thrombus of the left atrium goes through a trans-thoracic cardiac ultrasound and a transesophageal cardiac ultrasound. These examinations, often negative, are performed several days after the onset of the cerebral infarction. The transesophageal cardiac ultrasound, considered as the "gold standard" examination to look for an intracardiac thrombus and an embologenic plaque in the aortic arch, is poorly tolerated. It is rarely performed in patients over 75 years of age. In addition, the length of stay for these patients may increase due to the wait for these exams.

Several studies have validated the non-inferiority of the cardiac scanner compared to the transesophageal cardiac ultrasound for the detection of intracardiac thrombus (left atrium or left ventricle).

In the study by Hur et al. performed in 55 consecutive patients with a probable cardioembolic infarction, 14 thrombi of the left atrium were detected and confirmed by the cardiac scanner, but the patients were young, with a median age of 61 years. In the Berlin prospective HEBRAS study, 475 patients underwent cardiovascular MRI. The results are being analyzed but the cardiac scanner is more sensitive for the detection of thrombus in the left atrium.

A prospective study confirmed that the cardiac scanner is more precise in differentiating the left atrial thrombus from circulatory stasis in patients with stroke In this study, there is no information on the time between the stroke and the completion of the cardiac scanner.

Almost all patients with stroke benefit from an angio-scan of the CT scan of supra-aortic trunks as part of the urgent assessment on Day 1 or Day 2. The investigators propose to perform at the same time a cardiac scanner in order to allow a rapid morphological cardiological assessment, at the level of the left atrium, the left ventricle and the arch of the aorta.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient hospitalized in the Intensive NeuroVascular Care Unit of the GHPSJ after a first cerebral infarction or a recurrence
  • Patient who can benefit from a cardiac and ASD scan within 24 hours of admission and within 36 hours after the date of discovery of the cerebral infarction
  • Patient affiliated to a health insurance plan
  • French speaking patient
  • Patient or loved one having given their free, informed and written consent

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient with a contraindication to having a cardiac scanner and ASD (allergy to iodine, renal failure, pregnancy)
  • Patient with an obvious vascular cause (carotid or vertebral dissection, cerebral vasculitis, rare vascular causes of cerebral infarction)
  • Pregnant or lactating patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac scanner

As part of the usual care of patients hospitalized for stroke, the following examinations are carried out: a serum pregnancy test for women of childbearing age, a trans-thoracic cardiac ultrasound, a transesophageal cardiac ultrasound according to the needs of your care, an echo-doppler of the supraaortic trunks, a CT angiography of the supraaortic trunks (CT scan of the cerebral arteries), a transcranial Doppler, a biological assessment, a 24-hour holter or long-term holter.

Within 24 hours after admission: The cerebral artery scan, (usual care), is carried out and is supplemented by the additional examination of this research corresponding to a cardiac scanner (not requiring additional injection of contrast medium).

The following examinations of usual care are carried out within 3 days of inclusion: a trans-thoracic cardiac ultrasound, and a transesophageal cardiac ultrasound according to the needs of patient's care.
Other: Cardiac scanner

As part of the usual care of patients hospitalized for stroke, the following examinations are carried out: a trans-thoracic cardiac ultrasound, a transesophageal cardiac ultrasound according to the needs of patient's care, an echo-doppler of the supraaortic trunks, a CT angiography of the supraaortic trunks, a transcranial doppler, a biological assessment, a 24-hour holter or long-term holter.

The additional examination, specific to the research, corresponds to a cardiac scanner, which does not require the additional injection of contrast medium, carried out during the cerebral artery scanner within 36 hours of discovering the stroke. Within 3 days after inclusion, a trans-thoracic cardiac ultrasound, and a transesophageal cardiac ultrasound according to the needs of patient's care are carried out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac thrombus
Time Frame: Day 1
This outcome corresponds to the prevalence of cardiac thrombus on the Cardiac CT scan in the first hours after a cerebral infarction.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cardiac thrombi between 3 examinations
Time Frame: Day 3
This outcome corresponds to the comparison of the prevalence of thrombi between the cardiac scanner, the ETT and the ETO
Day 3
Determination of other cardioembolic causes
Time Frame: Day 3
This outcome corresponds to the number of patients for whom another cardioembolic cause has been discovered on the Cardiac CT scan.
Day 3
Modification of patient management
Time Frame: Day 3
This outcome corresponds to the number of cases where cardiac CT scan results have changed patient management.
Day 3
Evaluation of the reproducibility of the inter-observer technique
Time Frame: Month 18
This outcome corresponds to compare the reproducibility of the analysis of cardiac CT scan results between a junior radiologist and a senior radiologist on a sample of 60 files.
Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Ruben TAMAZYAN, MD, Groupe Hospitalier Paris Saint-Jospeh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

July 26, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCT STROKE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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