Acute StrokeBEHABISNCT03720522
The Bern Heart and Brain Interaction Study - Interaction Between Brain and Heart in Acute Ischemic Stroke
An observational study of Acute Stroke, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Acute ischemic stroke is caused by blockage of blood vessels in the brain. Blood vessels can be obstructed by several different mechanisms and identification of this cause is essential to minimize the risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Short cardiovascular MRI (CMR), Adenosine-perfusion cardiovascular MRI (CMR) and Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a diagnosis of acute ischemic stroke (< 12 h after symptom onset) confirmed by diffusion weighted MRI will be screened for further inclusion and exclusion criteria. This study includes exclusively vulnerable patients, with patients having a life-threatening acute ischemic stroke. The underlying disease needs emergency treatment including immediate management decisions under time pressure. There is no alternative group of patients in whom this study could be performed.
Who may be able to join
- Informed consent as documented by signature.
- Age: ≥ 18 and < 86 years.
- Acute ischemic stroke with symptom onset within 12 hours before admission to hospital.
- Diagnosis of acute ischemic stroke with MRI with diffusion restriction as seen on diffusion weighted imaging.
Who cannot join
- Pregnancy. A negative pregnancy test upon admission is required for all women with child-bearing potential.
- Standard contraindication for performing MRI.
- Severe renal failure (GFR <40).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Bern University Hospital - Inselspital
Bern, Canton of Bern, 3010
Simon Jung, PD Dr. med., simon.jung@insel.ch
Simon Jung, PD Dr. med.
About this study
Acute ischemic stroke is caused by blockage of blood vessels in the brain. Blood vessels can be obstructed by several different mechanisms and identification of this cause is essential to minimize the risk of recurrence.
Read the detailed description
Acute ischemic stroke is caused by blockage of blood vessels in the brain. This obstruction may be due to the presence of a blood clot, which prevents the passage of blood. Because the brain is under-irrigated, nerve cells lack oxygen and nutrients and can die, which can lead to brain function disorder.
Blood vessels can be obstructed by several different mechanisms and identification of this cause is essential to minimize the risk of recurrence. For instance, it may be a blood clot that originally formed in the heart, which breaks off and is carried away by the blood flow into an artery of the brain, which it blocks. The formation of such a clot can be caused by a heart attack, as a heart attack causes reduced mobility of certain parts of the heart, which greatly increases the risk of clot formation. At the same time, a stroke can also induce cardiac changes, for example because of the production of stress hormones secreted during a stroke. These cardiac changes due to stress hormones can greatly look like cardiac changes caused by a heart attack.
As a consequence, when a stroke is caused by a heart attack, it is often very difficult to correctly diagnose the heart attack and therefore treat patients properly. Indeed, symptoms and effects of a stroke and a heart attack may be similar, although these are two completely different medical problems. In order to gain additional knowledge, the investigators aim with this study to make the diagnosis of a heart attack more precise in patients suffering from a stroke.
Hypothesis, primary and secondary objectives:
The investigators postulate that the combination of laboratory, clinical, radiological, echocardiographic and electrophysiological assessments in a predictive score can distinguish myocardial infarction (MI) and neurogenic stunned myocardium (NSM) in stroke patients (MI and NSM defined by cardiac MRI and coronary angiography).
Primary objectives: The primary objective is to assess the prevalence of MI and NSM, with or without wall motion abnormalities, in stroke patients.
Secondary objectives: Secondary objectives aim to develop a predictive score out of laboratory, clinical, radiological (brain MRI), echocardiographic and electrophysiological parameters to identify stroke patients with MI and to distinguish them from patients with NSM.
The project will add important information to the pathogenesis of NSM, the importance of MI in stroke and the clinically relevant question of the management of stroke patients with hsTnT elevations. On one hand, the project offers the chance to improve the identification of patients with relevant coronary sclerosis. The investigators postulate that most of these patients are not identified by current practice. An early identification of these patients is necessary for early treatment and prevention of cardiac events.
On the other hand, the project offers the chance to improve the identification of patients with NSM and to deliver information on clinical relevance of NSM including arrhythmias and wall motion abnormalities. Given the negative association of NSM with outcome after stroke, the identification of NSM patients is the necessary condition for a treatment trial. Beta-blockers could for instance be beneficial for stroke patients with NSM and such a project could have far-reaching consequences on the management of many acute stroke patients in the near future.
- Conditions
- Acute Stroke
- Being tested
- Short cardiovascular MRI (CMR), Adenosine-perfusion cardiovascular MRI (CMR), Blood draw, Urine (collection over 24h)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short cardiovascular MRI (CMR)Procedure or surgery
A short CMR without additional contrast administration will be performed immediately after the routine brain MRI (at admission or after 24h).
Adenosine-perfusion cardiovascular MRI (CMR)Procedure or surgery
An adenosine-perfusion CMR using contrast medium (gadolinium) will be performed in all patients (except group 1) between 48h and 6 days after admission.
Blood drawProcedure or surgery
The following study-specific parameters will be tested: neuropeptide Y 1-36, neuropeptide Y 3-36, total plasma metanephrines, metabolomics analysis
Time points for blood draw: at admission (routine), 3h (routine), 24h (routine), 48h, 72h and 3 months.
Urine (collection over 24h)Procedure or surgery
The following study-specific parameters will be tested: catecholamines.
Time points for collection: at 24h, 72h, and 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients suffering from acute myocardial infarction | Patients with positive gadolinium late enhancement and positive intramyocardial oedema in the short CMR have an acute myocardial infarction and will be allocated to group 1. Receives: Procedure: Short cardiovascular MRI (CMR); Procedure: Blood draw; Procedure: Urine (collection over 24h) | |
| Group 2: Patients suffering from chronic myocardial infarction | Patients with elevated (≥ 0.015 mg/L) high sensitive troponin T (hsTnT) levels, positive gadolinium late enhancement and/or positive myocardial infarction suffer from chronic myocardial infarction or significant coronary stenosis. They will be allocated to group 2 and receive coronary angiography in a timely manner according to clinical routine and current guidelines. Receives: Procedure: Short cardiovascular MRI (CMR); Procedure: Adenosine-perfusion cardiovascular MRI (CMR); Procedure: Blood draw; Procedure: Urine (collection over 24h) | |
| Group 3: Patients suffering from stunned neurogenic myocardium | Patients with elevated (≥ 0.015 mg/L) high sensitive troponin T (hsTnT) levels and presence of wall motion abnormalities (WMA) have potential WMA due to neurogenic myocardial stunning. They will be allocated to group 3.
These patients will undergo a follow-up CMR without adenosine-perfusion after 3 months to confirm improvement/normalization of WMA.
Patients with normal (< 0.015mg/L) hsTnT levels and presence of WMA will also be allocated to group 3. Receives: Procedure: Short cardiovascular MRI (CMR); Procedure: Adenosine-perfusion cardiovascular MRI (CMR); Procedure: Blood draw; Procedure: Urine (collection over 24h) | |
| Group 4: Control | Patients with normal (< 0.015mg/L) high sensitive troponin T (hsTnT) levels without late enhancement, without myocardial infarction and without wall motion abnormalities will serve as control group and will be classified to group 4. Receives: Procedure: Short cardiovascular MRI (CMR); Procedure: Adenosine-perfusion cardiovascular MRI (CMR); Procedure: Blood draw; Procedure: Urine (collection over 24h) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)
Measured: 48 hours
Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)
Measured: 3 months
Secondary outcomes (4)
Prevalence of sub(acute) and chronic myocardial infarction in stroke patients with and without elevated hsTnT (≥ 0.015 mg/L)
Measured: At baseline, 24 hours, 48 hours, 3 months
Positive and negative predictive value of the developed predictive score to detect myocardial infarction and neurogenic stunned myocardium compared to CMR and coronary angiography
Measured: At baseline, 24 hours, 48 hours, 72 hours, 3 months
Influence of neurogenic stunned myocardium on neurological outcome (as measured by modified Rankin Scale)
The modified Rankin Scale (mRS) measures the degree of disability or dependence (minimum: 0 [normal]; maximum: 6 [death]). Favorable outcome is defined as a mRS score of 0 to 4, poor outcome as a mRS score of 5 or 6.
Measured: At baseline, 24 hours, 3 months
Influence of neurogenic stunned myocardium on brain infarct size (as measured by brain MRI)
Measured: At baseline, 24 hours, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Jung, PD Dr. med., Study director, Dep. of Neurology, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720522
- Sponsor's protocol ID
- 2018-01087
- Other IDs
- 2018
- Acronym
- BEHABIS
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2018
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bern Heart and Brain Interaction Study - Interaction Between Brain and Heart in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03720522
- Acronym / sponsor ID
- BEHABIS / 2018-01087
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Oct 2018 (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.
Acute ischemic stroke is caused by blockage of blood vessels in the brain. Blood vessels can be obstructed by several different mechanisms and identification of this cause is essential to minimize the risk of recurrence.
Detailed description
Acute ischemic stroke is caused by blockage of blood vessels in the brain. This obstruction may be due to the presence of a blood clot, which prevents the passage of blood. Because the brain is under-irrigated, nerve cells lack oxygen and nutrients and can die, which can lead to brain function disorder.
Blood vessels can be obstructed by several different mechanisms and identification of this cause is essential to minimize the risk of recurrence. For instance, it may be a blood clot that originally formed in the heart, which breaks off and is carried away by the blood flow into an artery of the brain, which it blocks. The formation of such a clot can be caused by a heart attack, as a heart attack causes reduced mobility of certain parts of the heart, which greatly increases the risk of clot formation. At the same time, a stroke can also induce cardiac changes, for example because of the production of stress hormones secreted during a stroke. These cardiac changes due to stress hormones can greatly look like cardiac changes caused by a heart attack.
As a consequence, when a stroke is caused by a heart attack, it is often very difficult to correctly diagnose the heart attack and therefore treat patients properly. Indeed, symptoms and effects of a stroke and a heart attack may be similar, although these are two completely different medical problems. In order to gain additional knowledge, the investigators aim with this study to make the diagnosis of a heart attack more precise in patients suffering from a stroke.
Hypothesis, primary and secondary objectives:
The investigators postulate that the combination of laboratory, clinical, radiological, echocardiographic and electrophysiological assessments in a predictive score can distinguish myocardial infarction (MI) and neurogenic stunned myocardium (NSM) in stroke patients (MI and NSM defined by cardiac MRI and coronary angiography).
Primary objectives: The primary objective is to assess the prevalence of MI and NSM, with or without wall motion abnormalities, in stroke patients.
Secondary objectives: Secondary objectives aim to develop a predictive score out of laboratory, clinical, radiological (brain MRI), echocardiographic and electrophysiological parameters to identify stroke patients with MI and to distinguish them from patients with NSM.
The project will add important information to the pathogenesis of NSM, the importance of MI in stroke and the clinically relevant question of the management of stroke patients with hsTnT elevations. On one hand, the project offers the chance to improve the identification of patients with relevant coronary sclerosis. The investigators postulate that most of these patients are not identified by current practice. An early identification of these patients is necessary for early treatment and prevention of cardiac events.
On the other hand, the project offers the chance to improve the identification of patients with NSM and to deliver information on clinical relevance of NSM including arrhythmias and wall motion abnormalities. Given the negative association of NSM with outcome after stroke, the identification of NSM patients is the necessary condition for a treatment trial. Beta-blockers could for instance be beneficial for stroke patients with NSM and such a project could have far-reaching consequences on the management of many acute stroke patients in the near future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients suffering from acute myocardial infarction | – | Procedure: Short cardiovascular MRI (CMR), Procedure: Blood draw, Procedure: Urine (collection over 24h)Patients with positive gadolinium late enhancement and positive intramyocardial oedema in the short CMR have an acute myocardial infarction and will be allocated to group 1. |
| Group 2: Patients suffering from chronic myocardial infarction | – | Procedure: Short cardiovascular MRI (CMR), Procedure: Adenosine-perfusion cardiovascular MRI (CMR), Procedure: Blood draw, Procedure: Urine (collection over 24h)Patients with elevated (≥ 0.015 mg/L) high sensitive troponin T (hsTnT) levels, positive gadolinium late enhancement and/or positive myocardial infarction suffer from chronic myocardial infarction or significant coronary stenosis. They will be allocated to group 2 and receive coronary angiography in a timely manner according to clinical routine and current guidelines. |
| Group 3: Patients suffering from stunned neurogenic myocardium | – | Procedure: Short cardiovascular MRI (CMR), Procedure: Adenosine-perfusion cardiovascular MRI (CMR), Procedure: Blood draw, Procedure: Urine (collection over 24h)Patients with elevated (≥ 0.015 mg/L) high sensitive troponin T (hsTnT) levels and presence of wall motion abnormalities (WMA) have potential WMA due to neurogenic myocardial stunning. They will be allocated to group 3. These patients will undergo a follow-up CMR without adenosine-perfusion after 3 months to confirm improvement/normalization of WMA. Patients with normal (< 0.015mg/L) hsTnT levels and presence of WMA will also be allocated to group 3. |
| Group 4: Control | – | Procedure: Short cardiovascular MRI (CMR), Procedure: Adenosine-perfusion cardiovascular MRI (CMR), Procedure: Blood draw, Procedure: Urine (collection over 24h)Patients with normal (< 0.015mg/L) high sensitive troponin T (hsTnT) levels without late enhancement, without myocardial infarction and without wall motion abnormalities will serve as control group and will be classified to group 4. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a diagnosis of acute ischemic stroke (< 12 h after symptom onset) confirmed by diffusion weighted MRI will be screened for further inclusion and exclusion criteria. This study includes exclusively vulnerable patients, with patients having a life-threatening acute ischemic stroke. The underlying disease needs emergency treatment including immediate management decisions under time pressure. There is no alternative group of patients in whom this study could be performed.
Key inclusion criteria (4 listed)
- Informed consent as documented by signature.
- Age: ≥ 18 and < 86 years.
- Acute ischemic stroke with symptom onset within 12 hours before admission to hospital.
- Diagnosis of acute ischemic stroke with MRI with diffusion restriction as seen on diffusion weighted imaging.
Key exclusion criteria (3 listed)
- Pregnancy. A negative pregnancy test upon admission is required for all women with child-bearing potential.
- Standard contraindication for performing MRI.
- Severe renal failure (GFR <40).
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 |
|---|---|---|
| Short cardiovascular MRI (CMR)A short CMR without additional contrast administration will be performed immediately after the routine brain MRI (at admission or after 24h). | Procedure or surgery | Group 1: Patients suffering from acute myocardial infarction, Group 2: Patients suffering from chronic myocardial infarction, Group 3: Patients suffering from stunned neurogenic myocardium, Group 4: Control |
| Adenosine-perfusion cardiovascular MRI (CMR)An adenosine-perfusion CMR using contrast medium (gadolinium) will be performed in all patients (except group 1) between 48h and 6 days after admission. | Procedure or surgery | Group 2: Patients suffering from chronic myocardial infarction, Group 3: Patients suffering from stunned neurogenic myocardium, Group 4: Control |
| Blood drawThe following study-specific parameters will be tested: neuropeptide Y 1-36, neuropeptide Y 3-36, total plasma metanephrines, metabolomics analysis Time points for blood draw: at admission (routine), 3h (routine), 24h (routine), 48h, 72h and 3 months. | Procedure or surgery | Group 1: Patients suffering from acute myocardial infarction, Group 2: Patients suffering from chronic myocardial infarction, Group 3: Patients suffering from stunned neurogenic myocardium, Group 4: Control |
| Urine (collection over 24h)The following study-specific parameters will be tested: catecholamines. Time points for collection: at 24h, 72h, and 3 months | Procedure or surgery | Group 1: Patients suffering from acute myocardial infarction, Group 2: Patients suffering from chronic myocardial infarction, Group 3: Patients suffering from stunned neurogenic myocardium, Group 4: Control |
Primary outcome
Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)
Time frame: 48 hours
Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)
Time frame: 3 months
4 secondary outcomes
Prevalence of sub(acute) and chronic myocardial infarction in stroke patients with and without elevated hsTnT (≥ 0.015 mg/L)
Time frame: At baseline, 24 hours, 48 hours, 3 months
Positive and negative predictive value of the developed predictive score to detect myocardial infarction and neurogenic stunned myocardium compared to CMR and coronary angiography
Time frame: At baseline, 24 hours, 48 hours, 72 hours, 3 months
Influence of neurogenic stunned myocardium on neurological outcome (as measured by modified Rankin Scale)
Time frame: At baseline, 24 hours, 3 months
Influence of neurogenic stunned myocardium on brain infarct size (as measured by brain MRI)
Time frame: At baseline, 24 hours, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Simon Jung, PD Dr. med. study director
Dep. of Neurology, Inselspital Bern
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 Acute Stroke, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Nov 2024. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Jung, PD Dr. med. (+41 31 632 79 56, simon.jung@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L) (time frame: 48 hours). 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?
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 22 Nov 2024.