StrokeNCT03830983
Atrial Cardiomyopathy in Patients With Stroke of Undetected Mechanism
An observational study of Stroke, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The goal of this study is to evaluate left atrial structural and functional abnormalities in stroke of undetected mechanism and atherosclerotic stroke with cardiac MRI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Mar 2019to 31 Jan 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are selected amongst individuals admitted with acute stroke to Bispebjerg University Hospital. Healthy controls will be invited from the the Copenhagen City Heart Study (ØBUS).
Who may be able to join
- Stroke of likely cardioembolic cause or of undetected mechanism:
- Lesions in at least one territory on MRI \& absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% in arteries supplying the ischemic area(s) \& absence of severe small vessel disease including micro-bleeds on MRI.
- Patients with central retinal artery occlusion documented by perimeter and absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% \& absence of severe small vessel disease including micro-bleeds on MRI are included independent of acute MRI findings.
- Large or small vessel stroke (atherosclerotic stroke):
- Large vessel stroke: Acute lesions in one vascular territory on MRI, significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% leading to the infarcted territory \& absence of severe small vessel disease including micro-bleeds on MRI Small Vessel stroke: MRI documenting lacunar infarction, absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% and presence of severe small vessel disease possibly including micro bleeds.
- Ischemic stroke within 30 days prior to inclusion
Show all 12Show fewer
- Age > 18 years
- Life expectancy of at least one year
- Informed consent
- Stenosis: % defined by Ultrasound
- Small vessel disease: defined according to STRIVE criteria
- 1. Age and sex matched healthy controls. Matched with the group with stroke of likely cardioembolic stroke.
Who cannot join
- Prior AF or AF >30 sec on at least 6 hours of monitoring during hospitalization.
- Other major cardio-embolic risk sources assumed as cause of stroke (e.g. endocarditis, myocardial infarction within last 4 weeks, prosthetic cardiac valve)
- Contraindications to MRI (Including eGFR<30 or other contraindications for the contrast agent used during Cardiac MRI)
- Assumed unable to participate in the study by investigator (including but not restricted to psychiatric condition, dementia)
- History of stroke or AF
- Contraindications to MRI (Including eGFR<30 mL/min/1.73 m2 or other contraindications for the contrast agent used during Cardiac MRI)
- Assumed unable to participate in the study by the investigator (For the same reasons listed above)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to evaluate left atrial structural and functional abnormalities in stroke of undetected mechanism and atherosclerotic stroke with cardiac MRI.
Read the detailed description
Aims and objectives:
The goal of this study is to evaluate left atrial structural and functional abnormalities in patients with stroke of likely cardio-embolic origin compared with healthy age and sex matches controls and patients with atherosclerotic stroke using cardiac MRI.
Background:
Despite standard work up for the etiology of ischemic stroke, about 30% of the cases remain unexplained. It is increasingly accepted that these unexplained cases arise from disease outside of the brain. Paroxysmal AF (Atrial fibrillation) may often be suspected as the source but fewer than one third of patients with stroke of undetermined source manifest AF in any form even after 3 years of continuous heart rhythm monitoring. Emerging evidence suggest that atrial functional and structural abnormalities may convey a comparable risk of stroke in which AF is only one of several features. These abnormalities have been termed "atrial cardiomyopathy" and may be an efficient and practical approach to identify patients at high risk of AF and ischemic stroke.
Methods and materials:
Cross sectional and prospective cohort study with 3 different groups: 50 patients with stroke of undetected mechanism, 50 patients with atherosclerotic stroke (large or small vessel disease) admitted to the University Hospital of Bispebjerg and Frederiksberg and 50 sex and age matched controls with no history of stroke or AF from the Copenhagen City Heart Study (ØBUS) will be included during a 2 year-period. The study will measure atrial structural abnormalities using cardiac magnetic resonance imaging (MRI) and atrial functional abnormalities by cardiac MRI and echocardiography. A 1 year follow up will examine the incidence of silent brain infarction with MRI and incidence of stroke, atrial fibrillation, acute myocardial infarction and cardiovascular death. Secondary endpoints are to examine the association of functional and structural changes found by MRI with echocardiography, rhythm abnormalities and biomarkers with the purpose of finding clinical easily applicable methods to diagnose atrial cardiomyopathy.
Expected outcome and perspectives:
The investigators hypothesize that patients with stroke of likely cardio-embolic origin have significantly more atrial fibrotic degeneration and reduced atrial emptying function than patients with atherosclerotic stroke and the control subjects. The investigators expect a higher incidence of silent brain infarction in the group with stroke of likely cardio-embolic origin. With atrial cardiomyopathy investigated thoroughly in patients with stroke of likely cardio-embolic origin the future work-up and treatment strategies could be more efficient and may thus improve the prognosis in terms of mortality and disability for a considerable number of patients.
- Conditions
- Stroke
- Keywords
- Cardioembolic stroke, Cardiac MRI, Heart disease, Vascular disease
- Medical subject headings
- Stroke, Embolic Stroke, Heart Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke of likely cardioembolic cause or undetected mechanism | Lesions in at least one territory on MRI \& absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% in arteries supplying the ischemic area(s) \& absence of severe small vessel disease including micro-bleeds on Patients with central retinal artery occlusion documented by perimeter and absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% \& absence of severe small vessel disease including micro-bleeds on MRI are included independent of acute MRI findings. | |
| Atherosclerotic stroke | Large vessel stroke: Acute lesions in one vascular territory on MRI, significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% leading to the infarcted territory \& absence of severe small vessel disease including micro-bleeds on MRI Small Vessel stroke: MRI documenting lacunar infarction, absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% and presence of severe small vessel disease possibly including micro bleeds. | |
| Controls | Age and sex matched healthy controls with no history of stroke or AF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of the fibrosis in the Left Atrium (LA)
Measured with gadolinium enhanced cardiac MRI
Measured: Within 12 weeks from index event
Left Atrial Emptying Function (LAEF)
Measured with gadolinium enhanced cardiac MRI
Measured: Within 12 weeks from index event
Secondary outcomes (12)
Observational study: Incidence of silent brain infarctions
Incidence of silent brain infarctions assessed by follow-up MR-cerebrum (Only in patients)
Measured: Between 1-2 years from index event
Left atrial volume
Assessed by cardiac MRI
Measured: Within 12 weeks from index event
Left atrial appendage morphology
Assessed by cardiac MRI
Measured: Within 8 weeks from index event
Left atrium volume
2D and 3D left atrial volume assessed by transthoracic echocardiography
Measured: Within 12 weeks from index event
Left atrium ejection fraction (LAEF)
Assessed by transthoracic echocardiography
Measured: Within 12 weeks from index event
Speckle tracking of LA
Assessed by transthoracic echocardiography
Measured: Within 12 weeks from index event
Atrial rhythm abnormalities: Number of premature atrial contractions (PAC) per hour. Number and length of runs of PAC
Assessed by 48-hours Holter monitoring
Measured: Within 4 weeks from index event
Heart rate variability (HRV)
Time domain variables (meanNN, SDNN, SDANN, SDNNidx, RMSSD, pNN50)
Measured: Within 4 weeks from index event
Thrombophilia biomarkers
Assessment of hypercoagulability
Measured: Within 12 weeks from index event
Cardiac specific biomarkers
Atrial Natriuretic Peptide, pro NT-Brain Natriuretic Peptide, High Sensitive Troponins.
Measured: Within 12 weeks from index event
Inflammatory biomarkers
High Sensitive CRP, Interleukins: IL1, IL1b, IL6, IL18
Measured: Within 12 weeks from index event
Fibrosis related markers
Collagen type I and III
Measured: Within 12 weeks from index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start8 Mar 2019
- Primary completion6 Sep 2021
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Lundbeck Foundation
- Responsible party
- Principal investigator, Ahmad Sajadieh, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Ahmad Sajadieh, MD, DMSc, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830983
- Sponsor's protocol ID
- 18055313
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be made available to other research groups upon reasonable request.
Publications
Larsen BS, Aplin M, Host N, Dominguez H, Christensen H, Christensen LM, Havsteen I, Prescott E, Jensen GB, Vejlstrup N, Bertelsen L, Sajadieh A. Atrial cardiomyopathy in patients with ischaemic stroke: a cross-sectional and prospective cohort study-the COAST study. BMJ Open. 2022 May 11;12(5):e061018. doi: 10.1136/bmjopen-2022-061018.
PubMed 35545392
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Cardiomyopathy in Patients With Stroke of Undetected Mechanism
- ClinicalTrials.gov ID
- NCT03830983
- Acronym / sponsor ID
- 18055313
- Conditions
- Stroke
- Keywords
- Cardioembolic stroke, Cardiac MRI, Heart disease, Vascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Lundbeck Foundation
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Feb 2019 (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.
The goal of this study is to evaluate left atrial structural and functional abnormalities in stroke of undetected mechanism and atherosclerotic stroke with cardiac MRI.
Detailed description
Aims and objectives:
The goal of this study is to evaluate left atrial structural and functional abnormalities in patients with stroke of likely cardio-embolic origin compared with healthy age and sex matches controls and patients with atherosclerotic stroke using cardiac MRI.
Background:
Despite standard work up for the etiology of ischemic stroke, about 30% of the cases remain unexplained. It is increasingly accepted that these unexplained cases arise from disease outside of the brain. Paroxysmal AF (Atrial fibrillation) may often be suspected as the source but fewer than one third of patients with stroke of undetermined source manifest AF in any form even after 3 years of continuous heart rhythm monitoring. Emerging evidence suggest that atrial functional and structural abnormalities may convey a comparable risk of stroke in which AF is only one of several features. These abnormalities have been termed "atrial cardiomyopathy" and may be an efficient and practical approach to identify patients at high risk of AF and ischemic stroke.
Methods and materials:
Cross sectional and prospective cohort study with 3 different groups: 50 patients with stroke of undetected mechanism, 50 patients with atherosclerotic stroke (large or small vessel disease) admitted to the University Hospital of Bispebjerg and Frederiksberg and 50 sex and age matched controls with no history of stroke or AF from the Copenhagen City Heart Study (ØBUS) will be included during a 2 year-period. The study will measure atrial structural abnormalities using cardiac magnetic resonance imaging (MRI) and atrial functional abnormalities by cardiac MRI and echocardiography. A 1 year follow up will examine the incidence of silent brain infarction with MRI and incidence of stroke, atrial fibrillation, acute myocardial infarction and cardiovascular death. Secondary endpoints are to examine the association of functional and structural changes found by MRI with echocardiography, rhythm abnormalities and biomarkers with the purpose of finding clinical easily applicable methods to diagnose atrial cardiomyopathy.
Expected outcome and perspectives:
The investigators hypothesize that patients with stroke of likely cardio-embolic origin have significantly more atrial fibrotic degeneration and reduced atrial emptying function than patients with atherosclerotic stroke and the control subjects. The investigators expect a higher incidence of silent brain infarction in the group with stroke of likely cardio-embolic origin. With atrial cardiomyopathy investigated thoroughly in patients with stroke of likely cardio-embolic origin the future work-up and treatment strategies could be more efficient and may thus improve the prognosis in terms of mortality and disability for a considerable number of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stroke of likely cardioembolic cause or undetected mechanism | – | –Lesions in at least one territory on MRI \& absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% in arteries supplying the ischemic area(s) \& absence of severe small vessel disease including micro-bleeds on Patients with central retinal artery occlusion documented by perimeter and absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% \& absence of severe small vessel disease including micro-bleeds on MRI are included independent of acute MRI findings. |
| Atherosclerotic stroke | – | –Large vessel stroke: Acute lesions in one vascular territory on MRI, significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% leading to the infarcted territory \& absence of severe small vessel disease including micro-bleeds on MRI Small Vessel stroke: MRI documenting lacunar infarction, absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% and presence of severe small vessel disease possibly including micro bleeds. |
| Controls | – | –Age and sex matched healthy controls with no history of stroke or AF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are selected amongst individuals admitted with acute stroke to Bispebjerg University Hospital. Healthy controls will be invited from the the Copenhagen City Heart Study (ØBUS).
Key inclusion criteria (12 listed)
- Stroke of likely cardioembolic cause or of undetected mechanism:
- Lesions in at least one territory on MRI \& absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% in arteries supplying the ischemic area(s) \& absence of severe small vessel disease including micro-bleeds on MRI.
- Patients with central retinal artery occlusion documented by perimeter and absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% \& absence of severe small vessel disease including micro-bleeds on MRI are included independent of acute MRI findings.
- Large or small vessel stroke (atherosclerotic stroke):
- Large vessel stroke: Acute lesions in one vascular territory on MRI, significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% leading to the infarcted territory \& absence of severe small vessel disease including micro-bleeds on MRI Small Vessel stroke: MRI documenting lacunar infarction, absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels >50% and presence of severe small vessel disease possibly including micro bleeds.
Key exclusion criteria (7 listed)
- Prior AF or AF >30 sec on at least 6 hours of monitoring during hospitalization.
- Other major cardio-embolic risk sources assumed as cause of stroke (e.g. endocarditis, myocardial infarction within last 4 weeks, prosthetic cardiac valve)
- Contraindications to MRI (Including eGFR<30 or other contraindications for the contrast agent used during Cardiac MRI)
- Assumed unable to participate in the study by investigator (including but not restricted to psychiatric condition, dementia)
- History of stroke or AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extent of the fibrosis in the Left Atrium (LA)
Time frame: Within 12 weeks from index event
Measured with gadolinium enhanced cardiac MRI
Left Atrial Emptying Function (LAEF)
Time frame: Within 12 weeks from index event
Measured with gadolinium enhanced cardiac MRI
12 secondary outcomes
Observational study: Incidence of silent brain infarctions
Time frame: Between 1-2 years from index event
Left atrial volume
Time frame: Within 12 weeks from index event
Left atrial appendage morphology
Time frame: Within 8 weeks from index event
Left atrium volume
Time frame: Within 12 weeks from index event
Left atrium ejection fraction (LAEF)
Time frame: Within 12 weeks from index event
Speckle tracking of LA
Time frame: Within 12 weeks from index event
Atrial rhythm abnormalities: Number of premature atrial contractions (PAC) per hour. Number and length of runs of PAC
Time frame: Within 4 weeks from index event
Heart rate variability (HRV)
Time frame: Within 4 weeks from index event
Thrombophilia biomarkers
Time frame: Within 12 weeks from index event
Cardiac specific biomarkers
Time frame: Within 12 weeks from index event
Inflammatory biomarkers
Time frame: Within 12 weeks from index event
Fibrosis related markers
Time frame: Within 12 weeks from index event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 35545392Larsen BS, Aplin M, Host N, Dominguez H, Christensen H, Christensen LM, Havsteen I, Prescott E, Jensen GB, Vejlstrup N, Bertelsen L, Sajadieh A. Atrial cardiomyopathy in patients with ischaemic stroke: a cross-sectional and prospective cohort study-the COAST study. BMJ Open. 2022 May 11;12(5):e061018. doi: 10.1136/bmjopen-2022-061018.
- Individual participant dataSharing planned: Undecided. De-identified data will be made available to other research groups upon reasonable request.
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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.
Ahmad Sajadieh, MD, DMSc principal investigator
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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 12 inclusion and 7 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: finished, as of the sponsor's last update on 31 Mar 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extent of the fibrosis in the Left Atrium (LA) (time frame: Within 12 weeks from index event). The study lists 2 primary outcomes in all. 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 NCT03830983, which also lists 1 linked publication.
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 31 Mar 2023.