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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: MOSTCAREup Monitoring; Device: Ecocardiography

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted for acute ischemic stroke

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Sovratentorial ischemic stroke

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).; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output measurement	Changes of cardiac output of the enrolled patients before and after clot removal.	Up to 6 hours after clot removal
Arterial elastance measurement	Changes of arterial elastance of the enrolled patients before and after clot removal.	Up to 6 hours after clot removal
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transthoracic echocardiography	Ejection Fraction measurement	at the admission
Transthoracic Echocardiography	wave E assessment	up to 3 weeks after clot removal
Transthoracic Echocardiography	wave A assessment	up to 3 weeks after clot removal
Transthoracic Echocardiography	wave e' assessment	up to 3 weeks after clot removal

Collaborators and Investigators

• Sponsor: Humanitas Clinical and Research Center
• Collaborators: Ospedale Policlinico San Martino

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: STROKE_EMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No