Zooming in on cerebral abnormalities in severely affected COVID-19 patients: a 3T and 7T MRI study

Recruiting

• Conditions: corona disease; COVID-19 infection; 10029305; 10024970

• Registration Number: NL-OMON53824
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 105

Inclusion Criteria

COVID-19 ICU survivors:
- Proven COVID-19 infection for which they were admitted to ICU for at least 3
days
- Included in the MaastrICCht cohort (a large database of serial measurements
collected during ICU stay from patients with COVID-19 admitted to the ICU in
het Maastricht University Medical Centre+; METC 2020-1565/3 00 523)
- Age >= 18 years
- Informed consent
- Sufficient command of the Dutch language to follow test instructions and
understand the information letter, informed consent, and questionnaires

ICU survivors:
- Admission to the intensive care unit at the Maastricht UMC+ for at least 3
days
- Reason for ICU admission: severe infection (bacterial, viral, fungal) with
respiratory insufficiency
- If tested for COVID-19 on ICU, negative PCR test result; if not tested for
COVID-19 on ICU, no suspicion for COVID-19 positive infection
- Age >= 18 years
- Informed consent
- Sufficient command of the Dutch language to follow test instructions and
understand the information letter, informed consent, and questionnaires

Exclusion Criteria

COVID-19 ICU survivors:
- Objective cognitive impairments before the hospital admission for the
COVID-19 infection
- An unexpected incident leading to severe neurological damage after hospital
discharge (such as stroke or traumatic brain injury)
- Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker,
claustrophobia, pregnancy and tattoos in the head/neck region)
- Unwillingness to be informed about clinical relevant (abnormal) MRI-findings
- Physical inability to travel to one of the locations (e.g., bedridden
patients)

ICU survivors:
- Positive COVID-19 PCR test during ICU admission
- Objective cognitive impairments before the ICU admission
- An unexpected incident leading to severe neurological damage after hospital
discharge (such as stroke or traumatic brain injury)
- Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker,
claustrophobia, pregnancy and tattoos in the head/neck region)
- Unwillingness to be informed about clinical relevant (abnormal) MRI-findings
- Physical inability to travel to one of the locations (e.g., bedridden
patients).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Radiological outcome at 12-24 months follow-up: MRI abnormalities, focussing on<br /><br>vascular abnormalities and olfactory tractus (3T MRI), and glymphatics and the<br /><br>brainstem (7T MRI). Neurological outcome: residual neurological symptoms<br /><br>(including smell/taste) and functional status at follow-up. Clinical outcome:<br /><br>severity of disease scores, (serial) factors of hypercoagulability and<br /><br>inflammation during ICU admission, neurological and cardiovascular<br /><br>(arterial/venous) complications during hospital admission. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Neuropsychological outcome: global deficits in cognitive and neurological<br /><br>functioning, objective changes in or loss of smell/taste and residual signs of<br /><br>inflammation and hypercoagulopathy at follow-up. </p><br>