AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Simon Jung, PD Dr. med. contact

+41 31 632 79 56

simon.jung@insel.ch

Switzerland1 site, 1 recruiting
  • Bern University Hospital - Inselspital

    Bern, Canton of Bern, 3010

    Simon Jung, PD Dr. med., simon.jung@insel.ch

    Simon Jung, PD Dr. med.

    Recruiting

Other trials in Switzerland

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 groups in NCT03720522
Study groupRoleWhat they receive
Group 1: Patients suffering from acute myocardial infarctionPatients 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 infarctionPatients 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 myocardiumPatients 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: ControlPatients 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.

  1. Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)

    Measured: 48 hours

  2. Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)

    Measured: 3 months

Secondary outcomes (4)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted25 Oct 2018
  2. Study start1 Dec 2018
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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