StrokeCCT STROKENCT04261257
Cardiac Thrombus in Early Cardiac CT Scan in Etiological Workup of Ischemic Stroke: Prospective Study
A study testing Cardiac scanner in people with Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cardiac scanner
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Stroke
- Being tested
- Cardiac scanner
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac scannerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac scanner | Experimental | 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. Receives: Other: Cardiac scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac thrombus
This outcome corresponds to the prevalence of cardiac thrombus on the Cardiac CT scan in the first hours after a cerebral infarction.
Measured: Day 1
Secondary outcomes (4)
Prevalence of cardiac thrombi between 3 examinations
This outcome corresponds to the comparison of the prevalence of thrombi between the cardiac scanner, the ETT and the ETO
Measured: Day 3
Determination of other cardioembolic causes
This outcome corresponds to the number of patients for whom another cardioembolic cause has been discovered on the Cardiac CT scan.
Measured: Day 3
Modification of patient management
This outcome corresponds to the number of cases where cardiac CT scan results have changed patient management.
Measured: Day 3
Evaluation of the reproducibility of the inter-observer technique
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.
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start11 Mar 2020
- Primary completion26 Jul 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben TAMAZYAN, MD, Principal investigator, Groupe Hospitalier Paris Saint-Jospeh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261257
- Sponsor's protocol ID
- CCT STROKE
- Acronym
- CCT STROKE
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2020
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cresti A, Garcia-Fernandez MA, Sievert H, Mazzone P, Baratta P, Solari M, Geyer A, De Sensi F, Limbruno U. Prevalence of extra-appendage thrombosis in non-valvular atrial fibrillation and atrial flutter in patients undergoing cardioversion: a large transoesophageal echo study. EuroIntervention. 2019 Jun 12;15(3):e225-e230. doi: 10.4244/EIJ-D-19-00128.
PubMed 30910768Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Left atrial appendage thrombi in stroke patients: detection with two-phase cardiac CT angiography versus transesophageal echocardiography. Radiology. 2009 Jun;251(3):683-90. doi: 10.1148/radiol.2513090794. Epub 2009 Apr 14.
PubMed 19366905Haeusler KG, Grittner U, Fiebach JB, Endres M, Krause T, Nolte CH. HEart and BRain interfaces in Acute ischemic Stroke (HEBRAS)--rationale and design of a prospective oberservational cohort study. BMC Neurol. 2015 Oct 22;15:213. doi: 10.1186/s12883-015-0458-2.
PubMed 26490042Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Cardiac computed tomographic angiography for detection of cardiac sources of embolism in stroke patients. Stroke. 2009 Jun;40(6):2073-8. doi: 10.1161/STROKEAHA.108.537928. Epub 2009 Apr 16.
PubMed 19372451Romero J, Husain SA, Kelesidis I, Sanz J, Medina HM, Garcia MJ. Detection of left atrial appendage thrombus by cardiac computed tomography in patients with atrial fibrillation: a meta-analysis. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):185-94. doi: 10.1161/CIRCIMAGING.112.000153. Epub 2013 Feb 13.
PubMed 23406625Ajlan AM, Bagdadi RR, Alama MN, Ayoub O. Impact of Implementing Cardiac CT in Evaluating Patients Suspected of Cardioembolic Stroke. J Comput Assist Tomogr. 2016 May-Jun;40(3):380-6. doi: 10.1097/RCT.0000000000000369.
PubMed 26854417Taina M, Vanninen R, Sipola P, Muuronen A, Jakala P, Hedman M. Cardiac CT Differentiates Left Atrial Appendage Thrombi from Circulatory Stasis in Acute Stroke Patients. In Vivo. 2016 09-10;30(5):671-6.
PubMed 27566089Shankar V, Bangdiwala SI. Observer agreement paradoxes in 2x2 tables: comparison of agreement measures. BMC Med Res Methodol. 2014 Aug 28;14:100. doi: 10.1186/1471-2288-14-100.
PubMed 25168681
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Thrombus in Early Cardiac CT Scan in Etiological Workup of Ischemic Stroke: Prospective Study
- ClinicalTrials.gov ID
- NCT04261257
- Acronym / sponsor ID
- CCT STROKE / CCT STROKE
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cardiac scanner | Experimental | Other: Cardiac scannerAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac scannerAs 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. | Other | Cardiac scanner |
Primary outcome
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.
4 secondary outcomes
Prevalence of cardiac thrombi between 3 examinations
Time frame: Day 3
Determination of other cardioembolic causes
Time frame: Day 3
Modification of patient management
Time frame: Day 3
Evaluation of the reproducibility of the inter-observer technique
Time frame: Month 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Results publication: PubMed 30910768Cresti A, Garcia-Fernandez MA, Sievert H, Mazzone P, Baratta P, Solari M, Geyer A, De Sensi F, Limbruno U. Prevalence of extra-appendage thrombosis in non-valvular atrial fibrillation and atrial flutter in patients undergoing cardioversion: a large transoesophageal echo study. EuroIntervention. 2019 Jun 12;15(3):e225-e230. doi: 10.4244/EIJ-D-19-00128.
- Results publication: PubMed 19366905Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Left atrial appendage thrombi in stroke patients: detection with two-phase cardiac CT angiography versus transesophageal echocardiography. Radiology. 2009 Jun;251(3):683-90. doi: 10.1148/radiol.2513090794. Epub 2009 Apr 14.
- Results publication: PubMed 26490042Haeusler KG, Grittner U, Fiebach JB, Endres M, Krause T, Nolte CH. HEart and BRain interfaces in Acute ischemic Stroke (HEBRAS)--rationale and design of a prospective oberservational cohort study. BMC Neurol. 2015 Oct 22;15:213. doi: 10.1186/s12883-015-0458-2.
- Results publication: PubMed 19372451Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Cardiac computed tomographic angiography for detection of cardiac sources of embolism in stroke patients. Stroke. 2009 Jun;40(6):2073-8. doi: 10.1161/STROKEAHA.108.537928. Epub 2009 Apr 16.
- Results publication: PubMed 23406625Romero J, Husain SA, Kelesidis I, Sanz J, Medina HM, Garcia MJ. Detection of left atrial appendage thrombus by cardiac computed tomography in patients with atrial fibrillation: a meta-analysis. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):185-94. doi: 10.1161/CIRCIMAGING.112.000153. Epub 2013 Feb 13.
- Results publication: PubMed 26854417Ajlan AM, Bagdadi RR, Alama MN, Ayoub O. Impact of Implementing Cardiac CT in Evaluating Patients Suspected of Cardioembolic Stroke. J Comput Assist Tomogr. 2016 May-Jun;40(3):380-6. doi: 10.1097/RCT.0000000000000369.
- Results publication: PubMed 27566089Taina M, Vanninen R, Sipola P, Muuronen A, Jakala P, Hedman M. Cardiac CT Differentiates Left Atrial Appendage Thrombi from Circulatory Stasis in Acute Stroke Patients. In Vivo. 2016 09-10;30(5):671-6.
- Results publication: PubMed 25168681Shankar V, Bangdiwala SI. Observer agreement paradoxes in 2x2 tables: comparison of agreement measures. BMC Med Res Methodol. 2014 Aug 28;14:100. doi: 10.1186/1471-2288-14-100.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben TAMAZYAN, MD principal investigator
Groupe Hospitalier Paris Saint-Jospeh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac scanner in people with Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac thrombus (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261257, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.