NCT02691286

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 22, 2016

Last Update Submit

February 24, 2016

Conditions

STEMICardiogenic ShockAcute Coronary SyndromemicroRNA

Outcome Measures

Primary Outcomes (1)

  • Mortality

    up to 6 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to Hospital de la Santa Creu i Sant Pau with diagnosis of STEMI with or without cardiogenic shock

You may qualify if:

  • Age \> 18 years
  • ST elevation by ECG diagnostic of STEMI
  • Evidency of coronary occlusion in coronariography
  • Signed informed consent

You may not qualify if:

  • Patients admitted from other hospitals
  • Impossibility of getting blood samples in first 6h
  • Declined consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08026, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA and LiHe tubes with 10 ml of blood

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionShock, CardiogenicAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Jordi Sans-Roselló, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Sans Roselló, M.D.

CONTACT

+34618779109jsans@santpau.cat

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 25, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

February 1, 2017

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)