STEMINCT02691286
Circulating microRNAs in Patients With STEMI Complicated With Cardiogenic Shock
An observational study of STEMI and Cardiogenic Shock, 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 study is knowing the prognostic value of circulating miRNAs in patients admitted to our hospital with STEMI complicated with cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, Cardiogenic Shock, Acute Coronary Syndrome
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Feb 2017
- 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: Patients admitted to Hospital de la Santa Creu i Sant Pau with diagnosis of STEMI with or without cardiogenic shock
Who may be able to join
- Age > 18 years
- ST elevation by ECG diagnostic of STEMI
- Evidency of coronary occlusion in coronariography
- Signed informed consent
Who cannot join
- Patients admitted from other hospitals
- Impossibility of getting blood samples in first 6h
- Declined consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08026
Jordi Sans Roselló, M.D, +34618779109, jsans@santpau.cat
JordI Sans-Roselló, M.D.
About this study
Official title: Prognostic Value of Circulating microRNAs in Patients With ST-elevation Myocardial Infarction (STEMI) Complicated by Cardiogenic Shock
The aim of the study is knowing the prognostic value of circulating miRNAs in patients admitted to our hospital with STEMI complicated with cardiogenic shock.
- Conditions
- STEMI, Cardiogenic Shock, Acute Coronary Syndrome, microRNA
- Medical subject headings
- ST Elevation Myocardial Infarction, Shock, Cardiogenic, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic Shock STEMI | Patients admitted to the hospital with the diagnosis with STEMI complicated with cardiogenic shock | |
| No Cardiogenic Shock STEMI | Patients admitted to the hospital with the diagnosis with STEMI without cardiogenic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Responsible party
- Sponsor
- Investigators
- Jordi Sans-Roselló, M.D., Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691286
- Sponsor's protocol ID
- IIBSP-RNA-2015-80
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Circulating microRNAs in Patients With ST-elevation Myocardial Infarction (STEMI) Complicated by Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT02691286
- Acronym / sponsor ID
- IIBSP-RNA-2015-80
- Conditions
- STEMI, Cardiogenic Shock, Acute Coronary Syndrome, microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- 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 study is knowing the prognostic value of circulating miRNAs in patients admitted to our hospital with STEMI complicated with cardiogenic shock.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic Shock STEMI | – | –Patients admitted to the hospital with the diagnosis with STEMI complicated with cardiogenic shock |
| No Cardiogenic Shock STEMI | – | –Patients admitted to the hospital with the diagnosis with STEMI without cardiogenic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Hospital de la Santa Creu i Sant Pau with diagnosis of STEMI with or without cardiogenic shock
Key inclusion criteria (4 listed)
- Age > 18 years
- ST elevation by ECG diagnostic of STEMI
- Evidency of coronary occlusion in coronariography
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients admitted from other hospitals
- Impossibility of getting blood samples in first 6h
- Declined consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Jordi Sans-Roselló, M.D. 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 STEMI and Cardiogenic Shock, 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 4 inclusion and 3 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 25 Feb 2016. 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?
Contact Jordi Sans Roselló, M.D. (+34618779109, jsans@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 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 25 Feb 2016.