NCT04127591

Brief Summary

The aim of this study is to determine the miRNA expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Typical duration 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

October 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

2.2 years

First QC Date

October 14, 2019

Last Update Submit

October 14, 2019

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Determination of differential expression of miRNA by second-generation sequencing technology

    Day 7

Secondary Outcomes (1)

  • Diagnostic value of the differential microRNAs evaluate by qPCR in patients of myocardial infarction

    Day 7

Study Arms (2)

myocardial infarction group

Patients admitted with the diagnosis of myocardial infarction.

Other: exosome

Blank control group

Patients admitted without the diagnosis of myocardial infarction.

Other: exosome

Interventions

exosomeOTHER

Collect exosomes in peripheral blood of patients and extract miRNAs from them.

Blank control groupmyocardial infarction group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of myocardial infarction

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 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

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Bin He

CONTACT

021-25077828hebinicu@139.com

Study Design

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

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 15, 2019

Study Start

October 20, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations

CN(1)