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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771468
• Other study ID #: STROKE_EMO
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Humanitas Clinical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• 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).
• 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.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center	Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output measurement	Changes of cardiac output of the enrolled patients before and after clot removal.	Up to 6 hours after clot removal
Primary	Arterial elastance measurement	Changes of arterial elastance of the enrolled patients before and after clot removal.	Up to 6 hours after clot removal
Primary	Arterial blood pressure measurement	Changes of arterial blood pressure of the enrolled patients before and after clot removal.	Up to 6 hours after clot removal
Primary	Heart rate variability measurement	Changes of heart rate variability of the enrolled patients before and after clot removal.	Up to 6 hours after clot removal
Secondary	Transthoracic echocardiography	Ejection Fraction measurement	at the admission
Secondary	Transthoracic Echocardiography	wave E assessment	up to 3 weeks after clot removal
Secondary	Transthoracic Echocardiography	wave A assessment	up to 3 weeks after clot removal
Secondary	Transthoracic Echocardiography	wave e' assessment	up to 3 weeks after clot removal