The Bern Heart and Brain Interaction Study - Interaction Between Brain and Heart in Acute Ischemic Stroke

ConditionAcute Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-86
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Short cardiovascular MRI (CMR)

    Procedure/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/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 draw

    Procedure/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/Surgery

    The following study-specific parameters will be tested: catecholamines. Time points for collection: at 24h, 72h, and 3 months

Treatment groups

220 Participants
are divided into 4 treatment groups
Group A: Group 1: Patients suffering from acute myocardial infarction3 interventions
Group B: Group 2: Patients suffering from chronic myocardial infarction4 interventions
Group C: Group 3: Patients suffering from stunned neurogenic myocardium4 interventions
Group D: Group 4: Control4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
48 hours
2

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

Time frame
3 months

Secondary outcomes

1

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
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

Time frame
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.

Time frame
At baseline, 24 hours, 3 months
4

Influence of neurogenic stunned myocardium on brain infarct size (as measured by brain MRI)

Time frame
At baseline, 24 hours, 3 months

Other outcomes

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