New Biomarkers of Neurological Outcome After a Sudden Cardiac Death

NCT03962361 | Unknown

• 1 other identifier: IIBPS-BIO-2015-56
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project is to establish the value of circulating microparticles as a new biomarker for neurological prognosis of patients recovered from sudden cardiac death who remain comatose.

Conditions

Cardiac Sudden Death; Hypoxia Brain; Cell Membrane Microparticles; Biomarkers

Keywords

Cardiac Sudden Death; Hypoxia Brain; Biomarkers; Cell-Derived Microparticles

Outcome Measures

Primary Outcomes (1)

• Change in Glasgow-Pittsburgh Cerebral Performance Categories Scale for neurological outcome.

  1. Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychologic deficit. 2. Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment. 3. Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis. 4. Coma or vegetative state: any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness. 5. Brain death: apnea, areflexia, EEG silence, etc.

  Change from Glasgow-Pittsburgh Cerebral Performance Categories Scale at 6 months

Secondary Outcomes (1)

• Cardiovascular mortality

  6 months

Study Arms (1)

Sudden cardiac death of ischemic cause

Patients admitted to the Coronary Care Unit for sudden cardiac death of ischemic cause and remain comatose (GCS \< 8 points).

Other: Concentration of circulating microparticles.

Interventions

Concentration of circulating microparticles. OTHER

The microparticles contained in the blood sample will be isolated by ultracentrifugation and quantified by flow cytometry. The microparticles concentration will be determined by the number of microparticles per uL of plasma, based on the volume of the sample, the flow rate of the cytometer and the number of fluorescent events.

Sudden cardiac death of ischemic cause

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include patients who have suffered a sudden cardiac death of ischemic cause admitted to the Coronary Care Unit of the Hospital de la Santa Creu i Sant Pau in Barcelona from the date of commencement of the study. The sample will be retrospectively completed with patients of the same features admitted to the unit since January 2012 and who have biological samples stored in the Biobank of Hospital de la Santa Creu i Sant Pau.

You may qualify if:

• Over 18 years old.
• Patients recovered from a sudden cardiac death (in-hospital and out-of-hospital) with return of spontaneous circulation (ROSC) (defined as systolic blood pressure \> 60 mmHg or palpable pulse for \> 5 minutes) who remain unconsciousness (defined as a score on the Glasgow Coma Scale \<8 ) for \> 5-10 minutes after ROSC.
• Treated with hypothermia as recommended by the European guidelines for resuscitation ( 2010)..

You may not qualify if:

• Non-cardiac sudden death.
• Active oncologic pathology .
• Traumatic or spontaneous intra-cranial haemorrhage.
• Inability to obtain required blood samples or refusal of the informed consent necessary for it.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples from patients enrolled in the study will be collected at admission, at 24 and at 72 hours. Blood collection will be obtained from arterial access whenever possible (otherwise preferably central or peripheral venous lines will be used without using tourniquet) and stored in tubes sodium citrate 3.8 %. Immediately after blood collection, the proteolipid protein fraction will be obtained by centrifugation fraction. To do this , samples will be centrifuged twice to exclude any cell rest. The aliquots obtained will be frozen first with liquid nitrogen and then stored at -80°C in the Biobank IIB Sant Pau until further analysis.

MeSH Terms

Conditions

Death, Sudden, Cardiac; Hypoxia, Brain

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Laia C Belarte, Doctor

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: May 24, 2019
• Study Start: February 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

ES (1)