Cardiac Sudden DeathNCT03962361
New Biomarkers of Neurological Outcome After a Sudden Cardiac Death
An observational study of Cardiac Sudden Death and Hypoxia Brain, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sudden Death, Hypoxia Brain, Cell Membrane Microparticles
- What is being tested?
- Concentration of circulating microparticles.
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)..
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles
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.
Read the 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.
- Being tested
- Concentration of circulating microparticles.
- Keywords
- Cardiac Sudden Death, Hypoxia Brain, Biomarkers, Cell-Derived Microparticles
- Medical subject headings
- Death, Sudden, Cardiac, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Concentration of circulating microparticles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Glasgow-Pittsburgh Cerebral Performance Categories Scale at 6 months
Secondary outcomes (1)
Cardiovascular mortality
Cardiovascular mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study startFeb 2016
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Sudden DeathStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laia C Belarte, Doctor, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962361
- Sponsor's protocol ID
- IIBPS-BIO-2015-56
- Status last verified
- May 2019
- First submitted
- 13 Jun 2016
- Last updated
- 24 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles
- ClinicalTrials.gov ID
- NCT03962361
- Acronym / sponsor ID
- IIBPS-BIO-2015-56
- Keywords
- Cardiac Sudden Death, Hypoxia Brain, Biomarkers, Cell-Derived Microparticles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sudden cardiac death of ischemic cause | – | Other: Concentration of circulating microparticles.Patients admitted to the Coronary Care Unit for sudden cardiac death of ischemic cause and remain comatose (GCS < 8 points). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)..
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Sudden cardiac death of ischemic cause |
Primary outcome
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.
1 secondary outcome
Cardiovascular mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laia C Belarte, Doctor principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Sudden Death and Hypoxia Brain, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glasgow-Pittsburgh Cerebral Performance Categories Scale for neurological outcome. (time frame: Change from Glasgow-Pittsburgh Cerebral Performance Categories Scale at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.