NCT01612611

Brief Summary

The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.

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
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

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

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

First QC Date

June 3, 2012

Last Update Submit

June 5, 2012

Conditions

ShockCoronary Heart Disease

Study Arms (1)

a cohort using Shenmai injection

Eligibility Criteria

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

all inpatients used Shenmai injection in 30 selected hospitals in mainland China

You may qualify if:

  • all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

Location

MeSH Terms

Conditions

ShockCoronary Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yan M Xie

    Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

June 3, 2012

First Posted

June 6, 2012

Study Start

January 1, 2012

Study Completion

December 1, 2015

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

CN(1)