An observational study in Cardiac Sudden Death, Hypoxia Brain and Cell Membrane Microparticles, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
Among 15 studies in Death, Sudden, Cardiac with a site in Spain — 7 open to participants now, 8 under way, 1 of them phase 3. Death, Sudden, Cardiac · Spain.
Among the 15 studies in Death, Sudden, Cardiac with a site in Spain, this one is one of 3 that started in 2016, is one of 8 observational ones, and was the 6th registered.
363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.
This study's enrollment of 84 is below the median of 449 across 202 observational studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →7 of the 15 studies in Death, Sudden, Cardiac with a site in Spain are open now.
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 63 Death, Sudden, Cardiac studies recruiting now, 41 (65%) set no upper age limit and 11 (17%) stop at 75 or younger; 21 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2016.
Median enrollment 400 across the 7 interventional studies, 1,643 across the 8 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
4 of 15 have an industry lead sponsor. The 10 most frequent:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau has 1 study filed under Death, Sudden, Cardiac — fewer than ten, so there is no comparison to draw.
4 of the studies in Death, Sudden, Cardiac with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04520347University of California, Los AngelesIVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry | 2026-12 |
| NCT05890716Idoven 1903 S.L.AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM) | 2026-12 |
| NCT06730607Centro Medico TeknonImage-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-control Study | 2026-12-30 |
| NCT05665608Charite University, Berlin, GermanyPrevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation | 2027-11-30 |
Among the 15 studies in Death, Sudden, Cardiac with a site in Spain, from their registry updates:
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Change from Glasgow-Pittsburgh Cerebral Performance Categories Scale at 6 months
Cardiovascular mortality
Cardiovascular mortality
Time frame: 6 months
The record gives a start of Feb 2016, a primary completion of Sep 2019 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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