New Biomarkers of Neurological Outcome After a Sudden Cardiac Death

Biomarkers Clinical Trial

Official title:

New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03962361
• Other study ID #: IIBPS-BIO-2015-56
• Status: Active, not recruiting
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarkers
• Cardiac Sudden Death
• Cell Membrane Microparticles
• Death
• Death, Sudden
• Death, Sudden, Cardiac
• Hypoxia
• Hypoxia Brain

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glasgow-Pittsburgh Cerebral Performance Categories Scale for neurological outcome.	Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychologic deficit.; Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.; Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.; 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.; Brain death: apnea, areflexia, EEG silence, etc.	Change from Glasgow-Pittsburgh Cerebral Performance Categories Scale at 6 months
Secondary	Cardiovascular mortality	Cardiovascular mortality	6 months