Coronary and Cerebral Microvascular Dysfunction in Neurological Diseases

NCT07009990 | Not Yet Recruiting

• 1 other identifier: G-HeBra
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Neurological and cardiovascular diseases are increasing in relative and absolute terms globally, and pose a major burden in terms of morbidity, mortality, quality of life and healthcare costs. Increasing evidence has been found that disorders of blood circulation in the smallest vessels of the heart and the brain share similar risk factors as well as mechanisms but evidence about the potential link between both remains scarce. Therefore, this study wants to investigate whether in patients with acute first-time stroke, first-time generalized epileptic seizure or first-time transient global amnesia, impairment in microcirculation is found in the brain and in the heart within 72 hours after the onset of first symptoms. We also intend to examine differences in structural brain as well as cardiac health parameters and in blood biomarkers between patients with acute neurological diseases and healthy controls matched for age, sex and major cardiovascular risk factors like diabetes, smoking and high blood pressure. In addition, we will characterize the cohorts in terms of cognitive function and questionnaires on lifestyle and self-reported emotional functioning. We expect lower circulation in the smallest blood vessels in the brain and in the heart in patients with acute neurological diseases compared to healthy controls. This pilot project is intended to demonstrate feasibility and initial results and thus serve as the basis for a larger clinical trial to improve long-term cerebral and cardiac health in patients with acute neurological diseases

Conditions

Stroke; Epilepsy; Transient Global Amnesia (TGA)

Keywords

neurological diseases; cardiovascular health; perfusion; microvascular dysfunction; magnetic resonance imaging; transthoracic echocardiogram; cognitive function; stroke; transient global amnesia; epilepsy; brain health; microcirculation; Takotsubo syndrome

Outcome Measures

Primary Outcomes (1)

• Microvascular function in the brain and heart

  For the brain, this will involve quantification of cerebral blood flow in the whole brain using arterial spin labeling magnetic resonance imaging technique. The cardiac microvascular function will be evaluated primarily through the measurement of coronary flow reserve with cardiac magnetic resonance imaging.

  at Baseline

Secondary Outcomes (9)

• Cerebral MRI

  at Baseline

• Cardiac MRI

  at Baseline

• Cardiac function and myocardial deformation

  at Baseline

• Microvascular endothelial function and coronary microvascular dysfunction

  at Baseline

• Blood Biomarkers related to heart function

  at Baseline

Study Arms (5)

Stroke patients

Patients who were referred to hospital due to an acute first-time stroke (ischemic or hemorrhage)

Epilepsy patients

Patients who were referred to hospital due to an first-time generalized epileptic seizure (with focal or generalized onset)

Transient global amnesia patients

Patients who were referred to hospital due to a transient global amnesia

Control group for stroke patients

Participants who were recruited from data repositories of young and older participants without pre-existing neurological disease who had agreed to be re-contacted for future studies; will match the patient group with acute first-time stroke in terms of age, sex, hypertension, diabetes and smoking

Control group for epilepsy and transient global amnesia patients

Participants who were recruited from data repositories of young and older participants without pre-existing neurological disease who had agreed to be re-contacted for future studies; will match the patient group with acute first-time generalized epileptic seizure and transient global amnesia in terms of age and sex

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with acute neurological event to the University Medicine Greifswald and healthy controls from the general population

You may qualify if:

• Men and women, minimum age: 45 years
• Gave informed consent
• Specifically for patient group: Admission to hospital due to an acute neurological event due to acute first-time stroke (ischemic or hemorrhage; mild to moderate in severity based on The National Institutes of Health Stroke Scale \[NIHSS\], score \<15) and able to provide informed consent (e.g., no or only mild aphasia; no impairment of consciousness), first-time generalized epileptic seizure (with focal or generalized onset), or transient global amnesia

You may not qualify if:

• History of stroke or any type of seizure
• Neurodegenerative neurological disorders including dementia, Parkinson's disease, Huntington's disease, and Amyotrophic lateral sclerosis
• Acute myocardial infarction requiring revascularization
• Severe and untreated medical conditions, including advanced-stage malignant tumors and cardiac diseases resulting in cardiogenic shock or acute heart failure
• Severe infections (C-Reactive Protein \[CRP\] \> 50 mg/dL)
• History of severe alcoholism or use of drugs
• Severe psychiatric disorders such as moderate to severe depression (if not in remission) or psychosis
• Contraindication to magnetic resonance imaging or renal dysfunction with eGFR (estimated glomerular filtration rate) \< 30 ml/min/1.73 m2, which would not allow the administration of the contrast agent gadolinium

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Department of Internal Medicine B, University Medicine Greifswald: collaborator
• Institute for Diagnostic Radiology and Neuroradiology University Medicine Greifswald: collaborator
• Department of Internal Medicine, First Clinic of Internal Medicine, University of Genoa, Italy: collaborator

Study Sites (1)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples (whole blood, serum, plasma)

MeSH Terms

Conditions

Stroke; Epilepsy; Amnesia, Transient Global; Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amnesia; Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cardiomyopathies; Heart Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Agnes Flöel, Prof. Dr.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Christian Templin, Prof. Dr. Dr.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Claudia Schwarz, Dr.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Davide Di Vece, Dr.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Flöel, Prof. Dr. med.

CONTACT

+49 (0)3834 86-6815; agnes.floeel@med.uni-greifswald.de

Claudia Schwarz, Dr.

CONTACT

+49 (0)3834 86-6815; claudia.schwarz@med.uni-greifswald.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)