Circulating microRNAs in Patients With STEMI Complicated... | NCT02691286

Studies
Circulating microRNAs in Patients With STEMI Complicated With Cardiogenic Shock

NCT02691286

Sponsor

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

Status

Unknown status

Last Update Posted

Feb 25, 2016Estimated

Enrollment

142Estimated

Phase

Not provided

Conditions

STEMI
Cardiogenic Shock
Acute Coronary Syndrome
microRNA

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Aug 2016Estimated

Completion Date

Feb 2017Estimated

First Submitted Date

Feb 22, 2016

First Submission Date that Met QC Criteria

Feb 24, 2016

First Posted Date

Feb 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2016

Last Update Posted Date

Feb 25, 2016Estimated

Name	Class
Spanish Society of Cardiology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

142Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Measure	Description	Time Frame
Mortality		up to 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jordi Sans Roselló, M.D.	Contact	+34618779109		jsans@santpau.cat

Overall Officials

Name	Affiliation	Role
Jordi Sans-Roselló, M.D.	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de la Santa Creu i Sant Pau	Recruiting	Barcelona	Barcelona	08026	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction
D012770	Shock, Cardiogenic
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided