New Biomarkers of Neurological Outcome After a Sudden Cardiac Death

• ClinicalTrials.gov Identifier: NCT03962361
• Recruitment Status: Unknown
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Information provided by (Responsible Party): Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description

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.

Condition or disease	Intervention/treatment
Cardiac Sudden Death; Hypoxia Brain; Cell Membrane Microparticles; Biomarkers	Other: Concentration of circulating microparticles.

Detailed Description:

This is a pilot study. Analytical, observational, longitudinal, retrospective and prospective, non-randomized. Patients recovered from sudden cardiac death of ischemic cause and remain comatose will be included in the protocol if they fit the pre-specified inclusion criteria. Biological samples will be collected (at admission, at 24 and 72 hours) and stored in the Biobank of Hospital de la Santa Creu i Sant Pau for further analysis. In addition demographic, clinical and analytical variables will be collected. At the end of the recruitment period, we will analyse the concentrations of circulating microparticles according to ICCC-IIBSantPau methodology in the samples obtained. The primary outcome variable will be the neurological status at Coronary Care Unit discharge and at 6 months. The objective of the study will evaluate the relationship between the neurological status and the blood concentrations of circulating microparticles.

Study Design

• Study Type: Observational
• Actual Enrollment: 84 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles
• Study Start Date: February 2016
• Estimated Primary Completion Date: September 2019
• Estimated Study Completion Date: December 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Glasgow-Pittsburgh Cerebral Performance Categories Scale for neurological outcome. [ Time Frame: Change from Glasgow-Pittsburgh Cerebral Performance Categories Scale at 6 months ]
   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.

Secondary Outcome Measures :

1. Cardiovascular mortality [ Time Frame: 6 months ]
   Cardiovascular mortality

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion Criteria:

• 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)..

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08026

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Laia C Belarte, Doctor; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

More Information

• Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• ClinicalTrials.gov Identifier: NCT03962361
• Other Study ID Numbers: IIBPS-BIO-2015-56
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

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

Additional relevant MeSH terms:

Death, Sudden, Cardiac; Death; Hypoxia; Death, Sudden; Pathologic Processes; Signs and Symptoms, Respiratory; Heart Arrest; Heart Diseases; Cardiovascular Diseases