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

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ClinicalTrials.gov Identifier: NCT04261257
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Other: Cardiac scanner Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Thrombus in Early Cardiac CT Scan in Etiological Workup of Ischemic Stroke: Prospective Study
Actual Study Start Date : March 11, 2020
Estimated Primary Completion Date : September 11, 2021
Estimated Study Completion Date : February 11, 2022

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261257


Contacts
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Contact: Ruben TAMAZYAN, MD 144128794 ext +33 rtamazyan@hpsj.fr
Contact: Helene BEAUSSIER, PharmD, PhD 144127038 ext +33 crc@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Ruben TAMAZYAN, MD    144128794 ext +33    rtamazyan@hpsj.fr   
Contact: Helene BEAUSSIER, PhD, PharmD    144127038 ext +33    crc@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Ruben TAMAZYAN, MD Groupe Hospitalier Paris Saint-Jospeh
Publications of Results:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04261257    
Other Study ID Numbers: CCT STROKE
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases