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

NCT03720522 | Recruiting

• 1 other identifier: 2018-01087
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (2)

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

  48 hours

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

  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)

  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

  At baseline, 24 hours, 48 hours, 72 hours, 3 months

• Influence of neurogenic stunned myocardium on neurological outcome (as measured by modified Rankin Scale)

  At baseline, 24 hours, 3 months

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

  At baseline, 24 hours, 3 months

Study Arms (4)

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.

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.

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.

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.

Procedure: Short cardiovascular MRI (CMR); Procedure: Adenosine-perfusion cardiovascular MRI (CMR); Procedure: Blood draw; Procedure: Urine (collection over 24h)

Interventions

Short cardiovascular MRI (CMR) PROCEDURE

A short CMR without additional contrast administration will be performed immediately after the routine brain MRI (at admission or after 24h).

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) PROCEDURE

An adenosine-perfusion CMR using contrast medium (gadolinium) will be performed in all patients (except group 1) between 48h and 6 days after admission.

Group 2: Patients suffering from chronic myocardial infarction; Group 3: Patients suffering from stunned neurogenic myocardium; Group 4: Control

Blood draw PROCEDURE

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.

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) PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital - Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Blood Specimen Collection; Urination

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Simon Jung, PD Dr. med.

  Dep. of Neurology, Inselspital Bern

  STUDY DIRECTOR

Central Study Contacts

Simon Jung, PD Dr. med.

CONTACT

+41 31 632 79 56; simon.jung@insel.ch

Marianne Kormann

CONTACT

+41 31 632 06 48; marianne.kormann@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 25, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)