A Registry of De Winter Symdrome of Single Center

• ClinicalTrials.gov Identifier: NCT03707496
• Recruitment Status: Unknown
• First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Sponsor: Hainan People's Hospital
• Information provided by (Responsible Party): Liao Wang, Hainan People's Hospital

Tracking Information

• First Submitted Date: October 8, 2018
• First Posted Date: October 16, 2018
• Last Update Posted Date: October 16, 2018
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 14, 2018)

Number of Participants with MACEs within 30 days [ Time Frame: 30 days ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 14, 2018)

• Number of participants with MACEs In-hospital [ Time Frame: throughout current hospitalization ]
  Number of participants with cardiac death,non-fatal myocardial infarction,stroke,heart failure in-hospital
• Number of Participants with MACEs within 7 days after admitted [ Time Frame: 7 days after admitted ]
  Number of participants with cardiac death,non-fatal myocardial infarction,stroke,heart failure in 7 days

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Registry of De Winter Symdrome of Single Center
• Official Title: A Registry of De Winter Symdrome of Hainan General Hospital
• 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.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 30 Days
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All acute coronary syndrome patients with a de Winter syndrome ECG pattern
• Condition: ACS - Acute Coronary Syndrome
• Intervention: Not Provided

Study Groups/Cohorts

DeWinterCohort

Patients with de Winter syndrome pattern ECG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 14, 2018): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2020
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

-No coronary angiography results was available during hospitalization

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03707496
• Other Study ID Numbers: Reg001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Liao Wang, Hainan People's Hospital
• Study Sponsor: Hainan People's Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hainan People's Hospital
• Verification Date: October 2018