Micro- and Macrovascular Parameters in Delayed Cerebral Ischemia

NCT05483751 | Recruiting DMC

• 1 other identifier: NL76189.068.21
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) results from a complex combination of macro- and microvascular processes. Besides cerebral vasospasms (CVS), DCI is caused by microthrombosis, neuroinflammation, microvascular dysfunction and cortical spreading depolarization.The glycocalyx plays an essential role in regulation of inflammation, oxidative stress and thrombosis, and could be involved in the pathophysiology of DCI. This study is a single-center prospective observational pilot (phase 1) and correlation (phase 2) study recruiting patients with an aneurysmal subarachnoid hemorrhage. The primary aim of the study is to evaluate the feasibility of performing measurements of the glycocalyx using side-stream darkfield (SDF) imaging sublingually and on the conjunctiva, and by sampling blood for analysis of markers of glycocalyx shedding. Moreover, the objective is to determine characteristic Doppler waveform morphologies in DCI patients by means of thorough analysis of transcranial Doppler (TCD) measurements. The secondary objective is to determine whether changes in glycocalyx integrity correlate with the development of DCI and whether these changes are associated with increased inflammation and with variation in TCD signals. Finally, changes in glycocalyx integrity, in TCD waveform morphology and in levels of inflammatory markers will be correlated with patient outcome at 6 weeks and 6 months after ictus.

Conditions

Delayed Cerebral Ischemia; Aneurysmal Subarachnoid Hemorrhage

Keywords

Delayed cerebral ischemia; Pathophysiology

Outcome Measures

Primary Outcomes (6)

• Success rate of measurements

  Number of successful measurements/ number of required measurements (%)

  2 weeks

• Rate of complications related to measurements

  Number of complications per patient and in total (%)

  2 weeks

• Communication speed between moment of inclusion and measurement, and DCI presentation and measurement

  Communication speed (hours)

  2 weeks

• Rate of patient-specific or software-related obstacles

  Number of obstacles/ number of patients (%)

  2 weeks

• Global perceived experience of the patient with the measurement

  5-point likert scale: "I could tolerate the measurement well": completely disagree, disagree, neutral, agree, completely agree

  2 weeks

• Patterns of Doppler signal morphology in aSAH and DCI patients

  Doppler signal waveforms (normalized with respect to time (ms) and velocity (cm/s)

  2 weeks

Secondary Outcomes (13)

• Width red blood cell column

  2 weeks

• Total perfused diameter

  2 weeks

• Perfused boundary region

  2 weeks

• Quantity of markers of glycocalyx breakdown

  2 weeks

• Quantity of inflammatory cytokines and enzymes

  2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients above 18 years of age admitted to MUMC+ with a SAH due to a ruptured intracranial aneurysm are eligible for inclusion in this study. Many conditions are known to affect glycocalyx integrity like diabetes mellitus type 1 and 2, stroke, hyperlipidemia, history of vasculitides, epilepsy, blood coagulation disorders or systemic inflammation. However, patients with these conditions will not be excluded from our study because these comorbidities are often seen in aSAH patients. Besides this, presence of these conditions will allow us to determine whether possible pre-existent glycoclayx disruption is associated with higher chances of developing DCI.

You may qualify if:

• age ≥ 18 years
• confirmed aneurysmal subarachnoid hemorrhage on CTA or DSA

You may not qualify if:

• imminent death within 24 hours
• other causes of subarachnoid hemorrhage like AVM or trauma
• language barrier
• ophthalmic or oral trauma or infection
• absent temporal bone window for TCD

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Neuroplast: collaborator
• NovaSignal Corp.: collaborator
• Glycocheck: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229HX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and cerebrospinal fluid

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roel Haeren, MD, PhD

CONTACT

+31433874041; roel.haeren@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 2, 2022
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-03

Locations

NL (1)