NCT07009990Not yet recruiting
Coronary and Cerebral Microvascular Dysfunction in Neurological Diseases
The Greifswald Heart and Brain Project: Coronary and Cerebral Microvascular Dysfunction in Patients With Acute Neurological Diseases
Source: ClinicalTrials.gov · Last updated 8 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 19 May 2025
- Start date
- Jun 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- University Medicine Greifswald
- NCT number
- NCT07009990
What you commit to
- Study type: Observational
- Planned participants: 100
- From Jun 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- History of severe alcoholism or use of drugs
- Severe psychiatric disorders such as moderate to severe depression (if not in remission) or psychosis
Lab values
- Severe infections (C-Reactive Protein \[CRP\] \> 50 mg/dL)
- 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
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medicine Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.