NCT03707496

Brief Summary

This registry started January 1,2018 to collect patients who diagnosed as De Winter Symdrome for the first time in Hainan General Hospital.All enrolled patients will receive 30 days followed-up.

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

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

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, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

October 8, 2018

Last Update Submit

April 11, 2021

Conditions

ACS - Acute Coronary Syndrome

Keywords

De Winter Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with MACEs within 30 days

    Number of participants with cardiac death,non-fatal myocardial infarction,stroke,heart failure in 30 days

    30 days

Secondary Outcomes (2)

  • Number of participants with MACEs In-hospital

    throughout current hospitalization

  • Number of Participants with MACEs within 7 days after admitted

    7 days after admitted

Study Arms (1)

DeWinterCohort

Patients with de Winter syndrome pattern ECG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All acute coronary syndrome patients with a de Winter syndrome ECG pattern

You may qualify if:

  • Index ECG ST segment showed a 1- to 3-mm upsloping ST-segment depression at the J point in leads V1 to V6 that continued into tall, positive symmetrical T waves
  • Received coronary angiography during hospitalization

You may not qualify if:

  • No coronary angiography results was available during hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hainan General Hospital

Haikou, Hainan, 570311, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Wang Liao, MD

CONTACT

13518827831crain_lw@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 16, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations

CN(1)