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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Short cardiovascular MRI (CMR)
Procedure/SurgeryA 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/SurgeryAn 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/SurgeryThe 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/SurgeryThe following study-specific parameters will be tested: catecholamines. Time points for collection: at 24h, 72h, and 3 months
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)
Prevalence of neurogenic stunned myocardium (NSM) in ischemic stroke patients with elevated hsTnT (≥ 0.015 mg/L)
Secondary outcomes
Prevalence of sub(acute) and chronic myocardial infarction in stroke patients with and without elevated hsTnT (≥ 0.015 mg/L)
Positive and negative predictive value of the developed predictive score to detect myocardial infarction and neurogenic stunned myocardium compared to CMR and coronary angiography
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.
Influence of neurogenic stunned myocardium on brain infarct size (as measured by brain MRI)
Sponsors and contacts
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