NCT04771468

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

January 6, 2021

Last Update Submit

September 1, 2021

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Transthoracic echocardiography

    at the admission

  • Transthoracic Echocardiography

    up to 3 weeks after clot removal

  • Transthoracic Echocardiography

    up to 3 weeks after clot removal

  • Transthoracic Echocardiography

    up to 3 weeks after clot removal

Study Arms (1)

Sovratentorial ischemic stroke

Device: MOSTCAREup MonitoringDevice: Ecocardiography

Interventions

MOSTCAREup MonitoringDEVICE

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).

Sovratentorial ischemic stroke
EcocardiographyDEVICE

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.

Sovratentorial ischemic stroke

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted for acute ischemic stroke

You may qualify if:

  • Adult patients aged ≥ 18 years.

You may not qualify if:

  • \. 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:
  • Intraoperative technical limitations limiting or impeding the arterial re-opening
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

February 25, 2021

Study Start

October 1, 2021

Primary Completion

June 1, 2022

Study Completion

December 31, 2022

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations

IT(1)