NCT03146494

Brief Summary

A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. For another, we will collect all the perioperative data of the STAAD group and study the role of thyroid function in the prognosis of STAAD.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

May 7, 2017

Last Update Submit

May 7, 2017

Conditions

Stanford Type A Aortic Dissection

Outcome Measures

Primary Outcomes (2)

  • The Role of Thyroid Function in the Development of STAAD.

    Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.

    30 days

  • The Role of Thyroid Function in the Prognosis of STAAD.

    Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.

    30 days

Study Arms (2)

STAAD

Normal

Eligibility Criteria

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

A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.

You may qualify if:

  • Adult patients with STAAD will underwent aortic surgery who are willing and able to give informed consent for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenjian Jiang

Beijing, Beijing Municipality, 100069, China

RECRUITING

Central Study Contacts

Wenjian Jiang, M.D.

CONTACT

+8618810252631jwj87427@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 10, 2017

Study Start

May 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

CN(1)