NCT02755207

Brief Summary

The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU).

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 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

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 24, 2020

Status Verified

April 1, 2019

Enrollment Period

4.1 years

First QC Date

March 29, 2016

Last Update Submit

February 21, 2020

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Evaluate the diagnostic value of microRNAs in qPCR，in ACS

    Day 7

Secondary Outcomes (1)

  • Evaluate the prognostic value of microRNAs in ACS

    6 months

Study Arms (2)

Suspected ACS group

Patients admitted to the hospital with the diagnosis of ACS

Blank control group

Patients admitted to the hospital without the diagnosis of ACS

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Suspected ACS patients (STEMI, NSTEMI, and UA)

You may qualify if:

  • Suspected ACS patients (STEMI, NSTEMI, and UA):
  • Age\>18 years; Informed consent.

You may not qualify if:

  • Patients who will undergo immediate PCI; Pregnant and lactating women; Patients with mental disorders; Patients are using other experimental drugs; Refusal to provide informed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

bin he

CONTACT

hebinicu@139.com

huimin cao

CONTACT

150128433@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D./Ph.D.

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 28, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

February 24, 2020

Record last verified: 2019-04

Locations

CN(1)