Coronary and Cerebral Microvascular Dysfunction in Neurological Diseases

NCT07009990 · tracked via the Priya Life Science Germany tracker

Sponsor

University Medicine Greifswald

Phase

Observational

Started

2025-06

Last updated

2025-06-08

Condition(s) studied

StrokeEpilepsyTransient Global Amnesia (TGA)

Study 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

Eligibility

Sex

ALL

Min age

45 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Microvascular function in the brain and heart — at Baseline
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.

Trial sites (1)

Facility	City	Region	Status
University Medicine Greifswald	Greifswald	Mecklenburg-Vorpommern

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07009990 on ClinicalTrials.gov ↗ ← All trials in Germany