Coronary and Cerebral Microvascular Dysfunction in Neurological Diseases (NCT07009990) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Coronary and Cerebral Microvascular Dysfunction in Neurological Diseases
Germany100 participantsStarted 2025-06
Plain-language 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
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.