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出境医 / 临床实验 / New Biomarkers of Neurological Outcome After a Sudden Cardiac Death

New Biomarkers of Neurological Outcome After a Sudden Cardiac Death

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
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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
Arms and Interventions
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
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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
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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
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Principal Investigator: Laia C Belarte, Doctor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Tracking Information
First Submitted Date June 13, 2016
First Posted Date May 24, 2019
Last Update Posted Date May 24, 2019
Study Start Date February 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 23, 2019) 		Cardiovascular mortality [ Time Frame: 6 months ]
Cardiovascular mortality
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title New Biomarkers of Neurological Outcome After a Sudden Cardiac Death
Official Title New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
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.
Condition
  • Cardiac Sudden Death
  • Hypoxia Brain
  • Cell Membrane Microparticles
  • Biomarkers
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.
Study Groups/Cohorts 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).
Intervention: Other: Concentration of circulating microparticles.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 23, 2019) 		84
Original Actual Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03962361
Other Study ID Numbers IIBPS-BIO-2015-56
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators Not Provided
Investigators
Principal Investigator: Laia C Belarte, Doctor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date May 2019

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