The Greifswald Heart and Brain Project: Coronary and Cerebral Microvascular Dysfunction in Patients With Acute Neurological Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Microvascular function in the brain and heart
研究概览
简要总结
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
详细描述
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 that microvascular dysfunction of the heart and the brain share similar disease risk factors as well as underlying pathophysiological mechanisms has been found but evidence about the potential link between both pathological processes is scarce.
This observational study will investigate whether in patients with acute neurological diseases (i.e., first-time acute stroke, first-time generalized epileptic seizure, or transient global amnesia [TGA]) without clinical evidence of acute coronary syndrome, microvascular dysfunction is found in the brain and in the heart within 72 hours (for TGA 24-72 hours) after onset of first symptoms.
A total of 60 in-patients who were referred to hospital due to an acute neurological disease including acute first-time stroke (ischemic or hemorrhage; N = 20), first-time generalized epileptic seizure (with focal or generalized onset; N = 20) and TGA (N = 20), will be included in the study. In parallel, two control groups of 20 individuals each will be recruited from data repositories of young and older participants without pre-existing neurological disease who had agreed to be re-contacted for future studies. One control group will match the patient group with acute first-time stroke in terms of age, sex, hypertension, diabetes and smoking. The other control group will match the patient groups with acute first-time generalized epileptic seizure and TGA in terms of age and sex.
Participants will be found in the University Medicine Greifswald, Department of Neurology, admitted to hospital due to an acute neurological event (i.e., first-time acute stroke, first-time generalized epileptic seizure, or TGA). The G-HeBra study team from Neurology will check daily with the Neurologist on call for new hospitalizations due to the aforementioned acute neurological events and those patients will be visited as soon as possible by the G-HeBra study team; to be informed about the study. The G-HeBra study team will ascertain inclusion and exclusion criteria with the patient. If the patient is suitable and willing to participate in the study after receiving both oral and written information, the patient will sign the informed consent. After giving written informed consent, an identification number will be assigned for pseudonymization. Informed consent may be revoked at any time without any reason.
Appointments for the different study assessments will be made within 72 hours (for TGA after 24 hours up to 72 hours) after onset of first symptoms. The collection of demographic data, neuropsychological tests, questionnaires and a standardized medical examination including blood sampling will be conducted during the same visit, if possible. Further visits will be scheduled for cerebral and cardiac magnetic resonance imaging (MRI), transthoracic echocardiography (TTE) with strain, measurement of microvascular endothelial function, and angiography-derived assessment of coronary microvascular function. All assessments will be conducted as early as possible after the acute neurological event.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Microvascular function in the brain and heart
时间窗: 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.
次要结局
- 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)
- Blood Biomarkers related to general health(at Baseline)
- Blood Biomarkers related to endothelial dysfunction(at Baseline)
- Blood Biomarkers related to brain injury(at baseline)
- Blood Biomarkers related to stress(at Baseline)
