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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04771468
Enrollment
50
Registered
2021-02-25
Start date
2021-10-01
Completion date
2022-12-31
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

DEVICEMOSTCAREup 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).

DEVICEEcocardiography

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.

Sponsors

Ospedale Policlinico San Martino
CollaboratorOTHER
Humanitas Clinical and Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Adult patients aged ≥ 18 years. 2. Acute supratentorial or carotid stroke.

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output measurementUp to 6 hours after clot removalChanges of cardiac output of the enrolled patients before and after clot removal.
Arterial elastance measurementUp to 6 hours after clot removalChanges of arterial elastance of the enrolled patients before and after clot removal.
Arterial blood pressure measurementUp to 6 hours after clot removalChanges of arterial blood pressure of the enrolled patients before and after clot removal.
Heart rate variability measurementUp to 6 hours after clot removalChanges of heart rate variability of the enrolled patients before and after clot removal.

Secondary

MeasureTime frameDescription
Transthoracic echocardiographyat the admissionEjection Fraction measurement
Transthoracic Echocardiographyup to 3 weeks after clot removalwave E assessment

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026