"Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".

NCT ID: NCT04771468

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-12-31

Brief Summary

Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sovratentorial ischemic stroke

MOSTCAREup Monitoring

Intervention Type: DEVICE

The patients will be equipped with mini-invasive hemodynamic monitoring (the MOSTACAREup system). The MOSTCAREup obtains the hemodynamic data from either the same arterial femoral line used by the neuro-radiologist to perform the treatment or from a dedicated radial artery, as decided by the attending anesthetist to monitor and optimize arterial pressure (the decision to use the arterial line is at discretion of the attending anesthetist for clinical reasons and does not delay the procedure, which starts using always the femoral access).

Ecocardiography

Intervention Type: DEVICE

Echocardiography will be performed 1) soon after the end of the treatment (whenever possible, avoiding delays, before od during the treatment in the angiography room); 2) at day 1 after the procedure; 3) at day 3 after the procedure.

Interventions

MOSTCAREup Monitoring

The patients will be equipped with mini-invasive hemodynamic monitoring (the MOSTACAREup system). The MOSTCAREup obtains the hemodynamic data from either the same arterial femoral line used by the neuro-radiologist to perform the treatment or from a dedicated radial artery, as decided by the attending anesthetist to monitor and optimize arterial pressure (the decision to use the arterial line is at discretion of the attending anesthetist for clinical reasons and does not delay the procedure, which starts using always the femoral access).

Intervention Type: DEVICE

Ecocardiography

Echocardiography will be performed 1) soon after the end of the treatment (whenever possible, avoiding delays, before od during the treatment in the angiography room); 2) at day 1 after the procedure; 3) at day 3 after the procedure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult patients aged ≥ 18 years.

Exclusion Criteria

1. Invasive arterial signal unsuitable to obtain hemodynamic data. 2. Emergency neurosurgery needed before intra-arterial treatment. 3. Once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions:

1. Intraoperative technical limitations limiting or impeding the arterial re-opening

2. Persistent low quality of the arterial signal. After positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Policlinico San Martino

OTHER

Sponsor Role: collaborator

Humanitas Clinical and Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Research Hospital

Rozzano, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Antonio Messina, MD

Role: primary

antonio.messina@humanitas.it

+390282241

Antonio Messina, MD

Role: backup

mess81rc@gmail.com

+3902822414131

Other Identifiers

STROKE_EMO

Identifier Type: -

Identifier Source: org_study_id