Coronary and Cerebral Microvascular Dysfunction in Neurological Diseases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversity Medicine Greifswald
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients admitted with acute neurological event to the University Medicine Greifswald and healthy controls from the general population
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 5 trial groupsGroup A: Stroke patients
Group B: Epilepsy patients
Group C: Transient global amnesia patients
Group D: Control group for stroke patients
Group E: Control group for epilepsy and transient global amnesia patients
Trial outcomes
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.
Time frame
at BaselineSecondary outcomes
1
Cerebral MRI
Cerebral structural measures (e.g. grey matter atrophy, white matter lesions), operationalized by different magnetic resonance imaging techniques including T1-weighted magnetization-prepared rapid acquisition gradient echo and fluid attenuated inversion recovery
Time frame
at Baseline2
Cardiac MRI
Analysis of myocardial perfusion reserve, myocardial blood flow, cine sequences, intravoxel incoherent motion, extracellular volume fraction and gadolinium enhancement to assess both functional and structural aspects of cardiac microvascular health and tissue characteristics
Time frame
at Baseline3
Cardiac function and myocardial deformation
Transthoracic echocardiography parameters, including left ventricular systolic and diastolic function, global longitudinal strain, left atrial strain and right ventricular systolic function
Time frame
at Baseline4
Microvascular endothelial function and coronary microvascular dysfunction
Microvascular endothelial function: non-invasively assessed by EndoPAT, a device that measures endothelial health through peripheral arterial tonometry. Coronary microvascular dysfunction: assessed with angiography-derived methods in form of index of microcirculatory resistance and coronary flow reserve. Only in patients undergoing coronary angiography due to a clinical indication.
Time frame
at BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medicine Greifswald
Lead sponsor
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
Source ClinicalTrials.gov
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